Roche Diagnostics Operations, Inc.
Also registered as Roche Diagnostics Operations, Roche Diagnostics Operations (Rdo)
United StatesFDA applicant, unverified
Roche Diagnostics Operations, Inc. is a medical device manufacturer, with 112 devices listed in FDA GUDID, FDA 510(k) and FDA PMA (FDA Class II, Class I, Class III and Unclassified) and 151 FDA recalls as of 14 Nov 2026.
- Devices
- 112
- FDA recalls
- 15110 ongoing since 2021 (14 open in total)
Registry facts
- Registries
- FDA GUDID 89
- FDA 510(k) 21
- FDA PMA 2
- Device classes
- FDA Class II 93
- FDA Class I 11
- FDA Class III 7
- FDA Unclassified 1
- FDA recalls
- Identifiers
- DUNS 141608724
At a glance
Market reach
- United States
- FDA recalls
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.
Catalogue
Search and filter all 112 devicesShowing 1-50 of 112
Company details
- DUNS number
- 141608724
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 16
- 2020 15
- 2021 6
- 2022 2
- 2023 1
- 2024 2
- 2025 1
- 2026 1
2026
- 20 Jan 2026 Z-1476-2026 Class II Ongoing 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.
2025
- 21 Nov 2025 Z-1009-2026 Class II Ongoing 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.
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- 21 Nov 2025 Z-1009-2026 Class II Ongoing 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.
2024
- 17 Oct 2024 Z-0489-2025 Class II Ongoing Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
- 15 Aug 2024 Z-3187-2024 Class II Ongoing 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.
2023
- 3 Oct 2023 Z-0352-2024 Class II Ongoing Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
2022
- 12 Dec 2022 Z-0952-2023 Class II Ongoing 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.
- 14 Jul 2022 Z-1515-2022 Class II Ongoing 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.
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2021
- 18 Oct 2021 Z-0266-2022 Class II 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.
- 24 Jun 2021 Z-2444-2021 Class II 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.
- 26 Apr 2021 Z-1675-2021 Class II Ongoing 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.
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Show the 25 most recent of 151 recalls
2021
- 7 Apr 2021 Z-1595-2021 Class II Ongoing 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.
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- 7 Apr 2021 Z-1596-2021 Class II Ongoing 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.
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- 6 Jan 2021 Z-1098-2021 Class II 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.
- 7 Apr 2021 Z-1595-2021 Class II Ongoing 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.
2020
- 17 Dec 2020 Z-0883-2021 Class II 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.
- 8 Dec 2020 Z-0754-2021 Class II Open since 2020 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.
- 8 Dec 2020 Z-0755-2021 Class II Open since 2020 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.
- 2 Dec 2020 Z-0803-2021 Class II 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
- 2 Dec 2020 Z-0804-2021 Class II 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
- 23 Nov 2020 Z-0752-2021 Class II 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).
- 6 Nov 2020 Z-0634-2021 Class II 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.
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- 9 Oct 2020 Z-0461-2021 Class II Terminated Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
- 31 Aug 2020 Z-0085-2021 Class II Open since 2020 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
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- 31 Aug 2020 Z-0086-2021 Class II Open since 2020 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
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- 27 Aug 2020 Z-0103-2021 Class III 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.
- 27 Aug 2020 Z-0104-2021 Class III 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.
Frequently asked questions
How many devices does Roche Diagnostics Operations, Inc. have in the registry?
The registry currently lists 112 devices for Roche Diagnostics Operations, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Roche Diagnostics Operations, Inc.'s devices?
Among its 50 most recently registered devices, Roche Diagnostics Operations, Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Roche Diagnostics Operations, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Roche Diagnostics Operations, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Roche Diagnostics Operations, Inc.?
FDA recall records list 151 recalls initiated by Roche Diagnostics Operations, Inc., the most recent initiated on 20 Jan 2026. 14 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Roche Diagnostics Operations, Inc. in the registry?
The most recently registered devices listed for Roche Diagnostics Operations, Inc. include ACCU-CHEK AVIVA 06870287001, ACCU-CHEK SMART VIEW 06334032001, ACCU-CHEK GUIDE 10436271001 and ACCU-CHEK AVIVA CONNECT 07049706001.