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Sign in to claim this brandRoche Diagnostics Operations, Inc.
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Last updated May 23, 2026
What Roche Diagnostics Operations, Inc. makes
The company produces in vitro diagnostics (IVDs) for glucose monitoring, including reagent kits and controls for spectrophotometric analysis, as well as home-use glucose analysers and companion software for diabetes management. It also manufactures reusable manual blood lancing devices and disposable lancing device tips designed for blood sampling.
These products are authorised under US FDA regulations, with devices classified as Class I, Class II, and Class III. They appear in FDA registries for 510(k) clearances, Premarket Approvals (PMA), and the Unique Device Identifier (UDI) database. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Roche Diagnostics Operations, Inc. primarily manufacture?
Roche Diagnostics Operations, Inc. specializes in in vitro diagnostics (IVDs) focused on glucose monitoring. Their portfolio includes reagent kits and controls for spectrophotometric glucose testing, home-use glucose analysers (like the ACCU-CHEK series), and companion software applications for diabetes management. They also produce reusable manual blood lancing devices and disposable lancing device tips for blood sampling, catering to both clinical and home healthcare settings.
Where is Roche Diagnostics Operations, Inc. based, and how does that affect its regulatory oversight?
The company is based in the United States, which means its devices are subject to FDA regulatory oversight under US regulations. Since the FDA classifies their products as Class I, Class II, or Class III—depending on risk level—they must comply with specific authorisation pathways, such as 510(k) clearances for lower-risk devices or Premarket Approval (PMA) for higher-risk Class III devices like certain glucose analysers.
Which regulatory registries list devices manufactured by Roche Diagnostics Operations, Inc.?
Devices from Roche Diagnostics Operations, Inc. appear in key FDA registries, including the 510(k) Premarket Notification Database for cleared lower-risk devices, the Premarket Approval (PMA) Application Database for higher-risk Class III products, and the Unique Device Identifier (UDI) Database for traceability and identification purposes. These registries reflect the company’s compliance with US FDA requirements for authorised devices.
How are the devices produced by Roche Diagnostics Operations, Inc. classified under FDA regulations?
The FDA categorises Roche Diagnostics Operations, Inc.’s devices into Class I, II, or III based on their risk levels. For example, disposable lancing device tips are typically Class I (low risk), while some glucose analysers or software applications may fall under Class II or III (moderate to high risk) due to their role in patient safety and diagnostic accuracy. Classification determines the regulatory pathway—such as 510(k) clearance for Class II or PMA for Class III—required for authorisation.
What distinguishes the home-use glucose analysers made by Roche Diagnostics Operations, Inc. from their clinical counterparts?
The company’s home-use glucose analysers (e.g., ACCU-CHEK PERFORMA or ACCU-CHEK SMART VIEW) are designed for patient self-monitoring of blood glucose levels outside clinical settings. These devices are authorised under the FDA’s Class II or Class III classifications, depending on their complexity and risk. Unlike clinical IVDs, they prioritise ease of use, portability, and integration with companion software (like ACCU-CHEK Inform II) for diabetes management, while still meeting stringent performance and safety standards for authorised use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 141608724
Catalogue (112)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Accu-Chek Aviva | 06870287001 | FDA UDI | Class II | Unknown |
| Accu-Chek Smart View | 06334032001 | FDA UDI | Class I | Active |
| Accu-Chek Guide | 10436271001 | FDA UDI | Class II | Active |
| Accu-Chek Aviva Connect | 07049706001 | FDA UDI | Class II | Unknown |
| Accu-Chek Compact Plus | 03149137001 | FDA UDI | Class II | Unknown |
| Accu-Chek Nano | 06333796002 | FDA UDI | Class II | Unknown |
| Accu-Chek Nano | 06333834001 | FDA UDI | Class II | Unknown |
| Accu-Chek Aviva Plus | 07021941001 | FDA UDI | Class II | Unknown |
| Accu-Chek Guide | 07400926001 | FDA UDI | Class II | Unknown |
| Accu-Chek Guide Me | 08499896001 | FDA UDI | Class II | Active |
| Accu-Chek Aviva Connect | 07049811001 | FDA UDI | Class II | Unknown |
| Accu-Chek Performa | 07299702001 | FDA UDI | Class II | Active |
| Relion | 09556672001 | FDA UDI | Class II | Active |
| Accu-Chek Guide Me | 08499900001 | FDA UDI | Class II | Active |
| Accu-Chek Guide | 08053723001 | FDA UDI | Class II | Active |
| Accu-Chek Aviva | 08350051001 | FDA UDI | Class II | Unknown |
| Accu-Chek Aviva Connect | 07049692001 | FDA UDI | Class II | Unknown |
| Accu-Chek Aviva Plus | 06988580001 | FDA UDI | Class II | Unknown |
| Accu-Chek Guide Link | 09651942001 | FDA UDI | Class III | Active |
| Accu-Chek Guide Link | 08116083022 | FDA UDI | Class III | Active |
| Accu-Chek Aviva Expert | 07189494001 | FDA UDI | Class II | Unknown |
| Accu-Chek Aviva Plus | 06908420002 | FDA UDI | Class II | Unknown |
| Accu-Chek Softclix | 09917764001 | FDA UDI | Class II | Active |
| Accu-Chek Nano | 07008325001 | FDA UDI | Class II | Unknown |
| Accu-Chek Aviva Plus | 06908152001 | FDA UDI | Class II | Unknown |
| Accu-Chek Aviva | 08350078001 | FDA UDI | Class II | Unknown |
| Accu-Chek Guide | 08256292001 | FDA UDI | Class II | Active |
| ACCU-CHEK Inform II | 05213509001 | FDA UDI | Class I | Active |
| Accu-Chek Aviva Plus | 06908349001 | FDA UDI | Class II | Active |
| Accu-Chek Compact Plus | 06444393001 | FDA UDI | Class II | Unknown |
| Accu-Chek Guide | 10439165001 | FDA UDI | Class II | Active |
| Exacta Glance | 09427937001 | FDA UDI | Class I | Active |
| Accu-Chek Compact Plus | 05177294001 | FDA UDI | Class II | Unknown |
| Accu-Chek Inform Ii | 05871166001 | FDA UDI | Class I | Active |
| Accu-Chek Connect | 07250452001 | FDA UDI | Class II | Active |
| Accu-Chek Aviva | 08340331001 | FDA UDI | Class II | Unknown |
| Accu-Chek Guide | 07453710001 | FDA UDI | Class II | Active |
| Accu-Chek Aviva Expert | 07162758001 | FDA UDI | Class II | Unknown |
| Accu-Chek Nano | 06333885001 | FDA UDI | Class II | Unknown |
| Accu-Chek Guide | 07400870001 | FDA UDI | Class II | Unknown |
| Accu-Chek Aviva Connect | 06979505001 | FDA UDI | Class II | Unknown |
| Accu-Chek Aviva Expert | 05075637005 | FDA UDI | Class II | Unknown |
| Accu-Chek Guide | 07400942001 | FDA UDI | Class II | Active |
| Accu-Chek Guide Link | 08109257001 | FDA UDI | Class III | Active |
| Instant White Label | 09397116001 | FDA UDI | Class II | Active |
| Accu-Chek Smart View | 06337562001 | FDA UDI | Class II | Active |
| Accu-Chek Aviva Combo | 05075645005 | FDA UDI | Class II | Unknown |
| Accu-Chek Inform Ii | 05942861001 | FDA UDI | Class II | Active |
| Accu-Chek Aviva Expert | 07189486001 | FDA UDI | Class II | Unknown |
| Accu-Chek Smart View | 06337538001 | FDA UDI | Class II | Active |
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FDA Recalls (100)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 20, 2026 | Z-1476-2026 | — | open, classified | Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel. |
| Nov 21, 2025 | Z-1009-2026 | — | open, classified | Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment. |
| Oct 17, 2024 | Z-0489-2025 | — | open, classified | Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias) |
| Aug 15, 2024 | Z-3187-2024 | — | open, classified | Creatine Kinase (CK) Assay Abnormal calibrations on the cobas c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis. |
| Oct 3, 2023 | Z-0352-2024 | — | open, classified | Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples. |
| Dec 12, 2022 | Z-0952-2023 | — | open, classified | A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the LIS. The erroneous event occurs under rare circumstances where the date in the sample's barcode does not match the order date sent from the LIS, and can lead to the order being mismatched to an another patient's sample ID rather than the subject patient's sample ID. The software bug impacts multiple cobas infinity central lab software (versions 2.5.x , 3.01.x, 3.02.x, and 3.03.x) and occurs when the afflicted software has been configured with specific pre-conditions. |
| Jul 14, 2022 | Z-1515-2022 | — | open, classified | Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG. |
| Oct 18, 2021 | Z-0266-2022 | — | terminated | A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. No interference of Nitrite results was observed at creatinine levels up to 9,000 mg/L. |
| Jun 24, 2021 | Z-2444-2021 | — | terminated | Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument. |
| Apr 26, 2021 | Z-1675-2021 | — | open, classified | Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer. |
| Apr 7, 2021 | Z-1595-2021 | — | open, classified | Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed. |
| Apr 7, 2021 | Z-1596-2021 | — | open, classified | Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed. |
| Jan 6, 2021 | Z-1098-2021 | — | terminated | May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision. If the unit for iCa++ is set to mg/dL (configured as Service Code MGL) and a measured iCa++ value is lower than the normal range, an upward arrow is shown on the display instead of a downward arrow. The display is set per default to mmol/L; therefore, the arrow indicating an alarm reflects normal ranges of iCa++ in mmol/L. If mg/dL is chosen, the arrow warnings on screen still reflect the ranges from mmol/L, rather than mg/dL. The numeric result is displayed correctly. |
| Dec 17, 2020 | Z-0883-2021 | — | terminated | A software error results in the unintentional removal of the serum-indices flag that would otherwise prevent the release of results. The Cobas Inifinity has an auto-verification feature to hold results for manual review when they meet specific criteria. The serum indices flag is used for serum indices tests that are performed to assess the quality of the sample (e.g. hemolysis, icterus, and lipemia). Normally, when the Cobas Infinity receives a result for a test that is serum indices-sensitive, it flags the result and the software then waits for the results of the serum indices tests before validating or rejecting the test result. Roche has discovered a software error that under specific conditions causes the flag to be incorrectly removed. This allows for the possibility that a sample of poor quality may return an unreliable/incorrect test result that is mistakenly reported to the health care provider and/or patient without the proper disclaimer that the result is based on a sample of poor quality. |
| Dec 8, 2020 | Z-0754-2021 | — | open, classified | Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags. |
| Dec 8, 2020 | Z-0755-2021 | — | open, classified | Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags. |
| Dec 2, 2020 | Z-0803-2021 | — | terminated | Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results |
| Dec 2, 2020 | Z-0804-2021 | — | terminated | Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results |
| Nov 23, 2020 | Z-0752-2021 | — | terminated | During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring). |
| Nov 6, 2020 | Z-0634-2021 | — | terminated | Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents. |
| Oct 9, 2020 | Z-0461-2021 | — | terminated | Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule |
| Aug 31, 2020 | Z-0085-2021 | — | open, classified | Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket |
| Aug 31, 2020 | Z-0086-2021 | — | open, classified | Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket |
| Aug 27, 2020 | Z-0104-2021 | — | terminated | Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents. |
| Aug 27, 2020 | Z-0103-2021 | — | terminated | Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents. |
| Aug 20, 2020 | Z-2981-2020 | — | terminated | Recent internal verification studies found the current RF interference claim to no longer be met for the assay on the cobas e 411, 601, and 602 analyzers. Therefore, the claim has been updated. |
| Feb 7, 2020 | Z-1444-2020 | — | terminated | The firm has received an increased number of complaints concerning non-reproducible elevated results ("high flyers") for one lot of Elecsys CA 19-9 reagent, which may affect clinical interpretation. |
| Jan 7, 2020 | Z-1158-2020 | — | terminated | Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen. |
| Oct 28, 2019 | Z-0669-2020 | — | terminated | Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10). |
| Oct 8, 2019 | Z-0922-2020 | — | terminated | Cobasinfinity laboratory solution Version 2.4.1 through Version 2.5.4 Using a CommServer Driver - Incorrect Alarm Mapping |
| Oct 4, 2019 | Z-0679-2020 | — | terminated | Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules |
| Sep 11, 2019 | Z-0153-2020 | — | terminated | Due to low Quality Control recovery and invalid Calibration. |
| Sep 11, 2019 | Z-0152-2020 | — | terminated | Due to low Quality Control recovery and invalid Calibration. |
| Aug 28, 2019 | Z-0108-2020 | — | terminated | Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference |
| Aug 28, 2019 | Z-0109-2020 | — | terminated | Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference |
| Aug 13, 2019 | Z-0044-2020 | — | terminated | AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results |
| Jul 23, 2019 | Z-0043-2020 | — | terminated | Inaccurately Low Sample Results |
| Jul 23, 2019 | Z-0042-2020 | — | terminated | Inaccurately Low Sample Results |
| Jul 18, 2019 | Z-2476-2019 | — | terminated | Quality issue with high pressure solenoid valves may cause inaccurate results. |
| Jul 18, 2019 | Z-2477-2019 | — | terminated | Quality issue with high pressure solenoid valves |
| Jul 18, 2019 | Z-2478-2019 | — | terminated | Quality issue with high pressure solenoid valves |
| Jul 16, 2019 | Z-2361-2019 | — | terminated | Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples. |
| Jul 16, 2019 | Z-2362-2019 | — | terminated | Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples. |
| Jul 2, 2019 | Z-2445-2019 | — | terminated | The firm conducted internal investigations that confirmed customer complaints of quality control (QC) imprecision and calibration failures for the Tina-quant Myoglobin Gen.2 assay (catalog number 04580010190), lot number 349860 on the cobas c311 analyzer and cobas c501 and c502 modules due to a drop in signal in the reaction kinetics. This signal drop was traced to an adjacent cell mixing effect. Sample recovery is decreased as a consequence of the disturbance in reaction kinetics. The investigation found discrepancies of up to -30%. Calibration, QC, and patient samples can be affected. The following issues were reported: - Calibration failures; Dup.E error due to signal drop in reaction kinetics - Sporadic quality control (QC) imprecision. As a long-term solution, the firm will implement required extra wash cycles (EWCs) into the respective Special Wash Requirements method sheets for the cobas c 311 analyzer and cobas c 501 and 502 modules, and into the cobas e-file for the cobas c 502 module. For the use of the reagent with the cobas c501 and c502, Roche will also direct users to run the Tina-Quant Myoglobin gen. 2 assay independently from other tests, in a batch mode status, with a maximum of 39 samples per run. Additionally, a change in the application settings of the Tina-quant Myoglobin Gen.2 assay on the cobas c 501 and 502 modules will be implemented so that adjacent cuvettes are no longer used in order to prevent adjacent cell mixing effects. The application settings change will be communicated at a later date. |
| Oct 31, 2016 | Z-0673-2017 | — | terminated | Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue is only detectable if comparison result of a second measurement is available. The cause for this issue is an error in the software measurement procedure. In children, decreased urea results can point at inborn disorders or urea cycle. Therefore, false normal urea values could lead to delayed/incorrect diagnosis of such a disorder. Besides the patients most at risk, the risk for the overall patient population with falsely low or high values is considered remote. No severe adverse health effects are expected; but, unnecessary diagnostic measures may be initiated. Falsely normal results may result in further necessary examination not being carried out, with the possibility of a delay in the diagnosis and treatment. A medical risk cannot entirely be excluded. |
| Oct 4, 2016 | Z-0396-2017 | — | terminated | .Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles. This issue occurred over multiple lots. Single cassettes/bottles of the reagents are affected. The issue can lead to erroneously high HbA1c results. |
| Oct 4, 2016 | Z-0395-2017 | — | terminated | Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles. This issue occurred over multiple lots. Single cassettes/bottles of the reagents are affected. The issue can lead to erroneously high HbA1c results. If a patient with known diabetes is affected, an erroneously high HbA1c result might lead to therapeutic consequences, such as therapy escalation (introduction of another oral antidiabetic medication or insulin) or increase of the dosage. This can further lead to an increased risk of hypoglycemia. Considering the unreliable detectability of the issue, relevant medical risk for the patient cannot entirely be excluded. |
| Sep 27, 2016 | Z-0387-2017 | — | terminated | cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002: 108000572, A software error occurred. This alarm is generated due to a measurement timing error. Under very rare conditions, the instrument may process two tests in the same cuvette if the run restarts. If a used cuvette is used again result of the test(s) will be erroneous. These erroneous results may not be flagged. Falsely low or high patient results may lead to incorrect diagnostic measures and medical therapeutic decisions. The medical risk depends on the parameter. |
| Jul 15, 2016 | Z-0095-2017 | — | terminated | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Jul 15, 2016 | Z-0100-2017 | — | terminated | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Jul 15, 2016 | Z-0105-2017 | — | terminated | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Jul 15, 2016 | Z-0108-2017 | — | terminated | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Jul 15, 2016 | Z-0098-2017 | — | terminated | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Jul 15, 2016 | Z-0099-2017 | — | terminated | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Jul 15, 2016 | Z-0109-2017 | — | terminated | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Jul 15, 2016 | Z-0096-2017 | — | terminated | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Jul 15, 2016 | Z-0106-2017 | — | terminated | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Jul 15, 2016 | Z-0101-2017 | — | terminated | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Jul 15, 2016 | Z-0102-2017 | — | terminated | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Jul 15, 2016 | Z-0107-2017 | — | terminated | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Jul 15, 2016 | Z-0103-2017 | — | terminated | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Jul 15, 2016 | Z-0110-2017 | — | terminated | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Jul 15, 2016 | Z-0097-2017 | — | terminated | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Jul 15, 2016 | Z-0104-2017 | — | terminated | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| Jul 15, 2016 | Z-0094-2017 | — | terminated | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. |
| May 26, 2016 | Z-2304-2016 | — | terminated | Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay on the cobas c 311/501/502 analyzers and the Modular Analytics P module due method sheets that state an incorrect method comparison against the COBAS INTEGRA 800 analyzer. |
| Mar 7, 2016 | Z-1276-2016 | — | terminated | Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used when monitoring patient being treated with fulvestrant. Customers should be informed that fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug. If treatment with fulvestrant has been altered or discontinued as a result of falsely elevated e |
| Mar 7, 2016 | Z-1277-2016 | — | terminated | Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used when monitoring patient being treated with fulvestrant. Customers should be informed that fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug. If treatment with fulvestrant has been altered or discontinued as a result of falsely elevated e |
| Feb 26, 2016 | Z-1092-2017 | — | terminated | Tina-quant Cardiac C-reactive Protein (Latex) High Sensitive (CRPHS) lot number 604450 (catalog number 11972855216) shows an under-recovery of up to -25% at concentrations below 5 mg/L on the MODULAR ANALYTICS P module. this issue can lead to erroneous low CRPHS results. CRPHS is used as a marker for the prediction of cardiovascular risk. An erroneous low result could lead to an incorrect cardiovascular risk assessment and subsequent delay of further examination. |
| Feb 23, 2016 | Z-1233-2016 | — | terminated | Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back in the Rack Tube Transport (RTT) after the decapping process. Therefore, open sample tubes can be dropped in the cobas p 512, spilling the sample material. |
| Feb 11, 2016 | Z-1172-2016 | — | terminated | Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The issue can lead to the data loss or in the worst case to an erroneous assignment of the patient data (patient mismatch). The issue will only occur at sites using POTCT1-A communication via USB. |
| Sep 22, 2015 | Z-0297-2016 | — | terminated | Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing. |
| Sep 3, 2015 | Z-1077-2017 | — | terminated | under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack change on the cobas b 123 <2> POC system and cobas b 123 <4> POC system. The issue occurs when the software function [AutoQC as follow-up] is configured to run all three levels of AutoQC only after a Fluid Pack change, but not after a Sensor Cartridge change. When both are changed simultaneously, starting with the Sensor Cartridge and followed by the Fluid Pack, the analyzer carries out only the follow-up actions associated with the Sensor Cartridge change after completing the change workflow. As a result, no follow-up AutoQC is performed and the three expected AutoQC measurements for the Fluid Pack change are not carried out. Without running quality control, there is a remote possibility that system issues would not be detected and wrong results would not be excluded on all parameters: pH, PO2, PCO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, SO2, O2Hb, COHb, MetHb, HHb, and Bili. |
| Jul 14, 2015 | Z-2446-2015 | — | terminated | Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused by a calibration issue with the PO2 parameter. This issue may not be detected since QC results can be below mean values, but still within 2 standard deviations (SD) limits. Potential for erroneously low PO2 results in patient samples, especially in blood samples with PO2 values below 50 mmHg |
| Jul 14, 2015 | Z-2447-2015 | — | terminated | Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused by a calibration issue with the PO2 parameter. This issue may not be detected since QC results can be below mean values, but still within 2 standard deviations (SD) limits. Potential for erroneously low PO2 results in patient samples, especially in blood samples with PO2 values below 50 mmHg |
| Jun 24, 2015 | Z-2330-2015 | — | terminated | The affected S2 fluid packs may generate a transponder error when the fluid pack is loaded on to the cobas b 221 system. The error prevents the fluid from being recognized by the system and the instrument cannot start measurements until the affected S2 Fluid Pack is replaced. |
| May 7, 2015 | Z-1927-2015 | — | terminated | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine. |
| May 7, 2015 | Z-1928-2015 | — | terminated | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine. |
| May 7, 2015 | Z-1925-2015 | — | terminated | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine. |
| May 7, 2015 | Z-1924-2015 | — | terminated | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine. |
| May 7, 2015 | Z-1930-2015 | — | terminated | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine. |
| May 7, 2015 | Z-1931-2015 | — | terminated | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine. |
| May 7, 2015 | Z-1929-2015 | — | terminated | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine. |
| May 7, 2015 | Z-1920-2015 | — | terminated | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine. |
| May 7, 2015 | Z-1923-2015 | — | terminated | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine. |
| May 7, 2015 | Z-1921-2015 | — | terminated | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine. |
| May 7, 2015 | Z-1926-2015 | — | terminated | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine. |
| May 7, 2015 | Z-1922-2015 | — | terminated | Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine plus and Uric Acid applications only) or blood samples collected before sufficient time has lapsed after the administration of the drugs Acetaminophen and N-acetylcysteine. |
| Mar 23, 2015 | Z-1622-2015 | — | terminated | Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst case, lead to inaccurately low Homocysteine results. An elevated level of Homocysteine is considered an important risk factor in the assessment of peripheral vascular disease. Falsely low values could lead to a delay of di |
| Dec 18, 2014 | Z-1041-2015 | — | terminated | Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positive bias up to 39% at 4.1 mmol/l for the glucose measurement and 30% at 4.12 mmol/l for lactate. Urea readings are unaffected. |
| Nov 20, 2014 | Z-0887-2015 | — | terminated | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify |
| Nov 20, 2014 | Z-0883-2015 | — | terminated | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify |
| Nov 20, 2014 | Z-0894-2015 | — | terminated | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify |
| Nov 20, 2014 | Z-0889-2015 | — | terminated | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify |
| Nov 20, 2014 | Z-0885-2015 | — | terminated | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify |
| Nov 20, 2014 | Z-0888-2015 | — | terminated | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify |
| Nov 20, 2014 | Z-0892-2015 | — | terminated | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify |
| Nov 20, 2014 | Z-0891-2015 | — | terminated | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify |
| Nov 20, 2014 | Z-0893-2015 | — | terminated | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify |
| Nov 20, 2014 | Z-0890-2015 | — | terminated | Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached at the connect/disconnect location on the ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets. If tubing detachment occurs, insulin delivery is interrupted and the pump will not alarm to notify |