{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Roche Diagnostics Operations, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/roche-diagnostics-operations-inc (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/roche-diagnostics-operations-inc",
    "json_url": "https://devicerts.com/manufacturers/roche-diagnostics-operations-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/roche-diagnostics-operations-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "FDA PMA",
        "url": "https://open.fda.gov/apis/device/pma/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "eudamed_record_synced": null,
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-14",
    "status_as_of": "2026-11-14",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/manufacturers/roche-diagnostics-operations-inc",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "manufacturer": {
    "name": "Roche Diagnostics Operations, Inc.",
    "url": "https://devicerts.com/manufacturers/roche-diagnostics-operations-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [
      "Roche Diagnostics Operations",
      "Roche Diagnostics Operations (Rdo)"
    ],
    "country": "United States",
    "country_basis": "FDA applicant, unverified",
    "eudamed_status": null,
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [],
    "identifiers": [
      {
        "label": "DUNS",
        "value": "141608724"
      }
    ],
    "summary": "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.",
    "noindex": false
  },
  "counts": {
    "devices": 112,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 151,
    "fda_recalls_ongoing": 14,
    "fda_recalls_ongoing_recent": 10,
    "fda_recalls_ongoing_before": {
      "year": 2021,
      "count": 4
    },
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA GUDID",
        "devices": 89
      },
      {
        "registry": "FDA 510(k)",
        "devices": 21
      },
      {
        "registry": "FDA PMA",
        "devices": 2
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class II",
        "devices": 93
      },
      {
        "class": "FDA Class I",
        "devices": 11
      },
      {
        "class": "FDA Class III",
        "devices": 7
      },
      {
        "class": "FDA Unclassified",
        "devices": 1
      }
    ],
    "top_emdn_categories": []
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": []
  },
  "devices": {
    "shown": 50,
    "total": 112,
    "all_devices_url": "https://devicerts.com/manufacturers/roche-diagnostics-operations-inc",
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      {
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      {
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      {
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      {
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        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": [
    {
      "number": "Z-1476-2026",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2026-01-20",
      "product_code": "JJE",
      "reason": "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."
    },
    {
      "number": "Z-1009-2026",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2025-11-21",
      "product_code": "JZO",
      "reason": "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."
    },
    {
      "number": "Z-0489-2025",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2024-10-17",
      "product_code": "LPS",
      "reason": "Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)"
    },
    {
      "number": "Z-3187-2024",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2024-08-15",
      "product_code": "JHS",
      "reason": "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."
    },
    {
      "number": "Z-0352-2024",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2023-10-03",
      "product_code": "GHH",
      "reason": "Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples."
    },
    {
      "number": "Z-0952-2023",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2022-12-12",
      "product_code": "JQP",
      "reason": "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."
    },
    {
      "number": "Z-1515-2022",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2022-07-14",
      "product_code": "JJE",
      "reason": "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."
    },
    {
      "number": "Z-0266-2022",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2021-10-18",
      "product_code": "KQO",
      "reason": "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."
    },
    {
      "number": "Z-2444-2021",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2021-06-24",
      "product_code": "JQP",
      "reason": "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."
    },
    {
      "number": "Z-1675-2021",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2021-04-26",
      "product_code": "JJE",
      "reason": "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."
    },
    {
      "number": "Z-1595-2021",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2021-04-07",
      "product_code": "MMI",
      "reason": "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."
    },
    {
      "number": "Z-1596-2021",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2021-04-07",
      "product_code": "MMI",
      "reason": "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."
    },
    {
      "number": "Z-1098-2021",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2021-01-06",
      "product_code": "JFP",
      "reason": "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."
    },
    {
      "number": "Z-0883-2021",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2020-12-17",
      "product_code": "JQP",
      "reason": "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."
    },
    {
      "number": "Z-0754-2021",
      "classification": "Class II",
      "status": "Open since 2020",
      "initiated": "2020-12-08",
      "product_code": "JJE",
      "reason": "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."
    },
    {
      "number": "Z-0755-2021",
      "classification": "Class II",
      "status": "Open since 2020",
      "initiated": "2020-12-08",
      "product_code": "JJE",
      "reason": "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."
    },
    {
      "number": "Z-0803-2021",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2020-12-02",
      "product_code": "GJS",
      "reason": "Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing  instructions to users for ensuring the meter is displaying INR results"
    },
    {
      "number": "Z-0804-2021",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2020-12-02",
      "product_code": "GJS",
      "reason": "Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing  instructions to users for ensuring the meter is displaying INR results"
    },
    {
      "number": "Z-0752-2021",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2020-11-23",
      "product_code": "JJE",
      "reason": "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)."
    },
    {
      "number": "Z-0634-2021",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2020-11-06",
      "product_code": "DCN",
      "reason": "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."
    },
    {
      "number": "Z-0461-2021",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2020-10-09",
      "product_code": "JQP",
      "reason": "Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using  Status Expiration Control  Rule"
    },
    {
      "number": "Z-0085-2021",
      "classification": "Class II",
      "status": "Open since 2020",
      "initiated": "2020-08-31",
      "product_code": "KPA",
      "reason": "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"
    },
    {
      "number": "Z-0086-2021",
      "classification": "Class II",
      "status": "Open since 2020",
      "initiated": "2020-08-31",
      "product_code": "KPA",
      "reason": "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"
    },
    {
      "number": "Z-0103-2021",
      "classification": "Class III",
      "status": "Terminated",
      "initiated": "2020-08-27",
      "product_code": "DBI",
      "reason": "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."
    },
    {
      "number": "Z-0104-2021",
      "classification": "Class III",
      "status": "Terminated",
      "initiated": "2020-08-27",
      "product_code": "CIX",
      "reason": "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."
    }
  ]
}