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Roche Diagnostics GmbH

Germany DE-MF-000006260 Last updated 23 Oct 2026

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Devices
23
Registries
EUDAMEDGUDIDFDA 510(k)FDA PMAFDA
FDA recalls
240

Catalogue23

EUDAMED certificates6

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (6)

TÜV SÜD Product Service GmbH 0123 6 certificates

  • V76 010283 0744 Reissued

    Technical documentation EU IVDR

    Issued
    25 Aug 2026
    Expires
    23 Sep 2031
    Valid from
    24 Sep 2026
  • V76 010283 0739 Issued

    Technical documentation EU IVDR

    Issued
    14 Sep 2026
    Expires
    13 Sep 2031
  • V76 010283 0742 Issued

    Technical documentation EU IVDR

    Issued
    14 Aug 2026
    Expires
    13 Aug 2031
  • V76 010283 0738 Supplemented

    Technical documentation EU IVDR

    Issued
    2 Jul 2026
    Expires
    20 Nov 2029
    Reason
    Change approved
  • V75 010283 0684 Supplemented

    Technical documentation EU IVDR

    Issued
    28 May 2026
    Expires
    27 Mar 2029
    Reason
    Change approved
  • V70 010283 0676 Supplemented

    Technical documentation EU IVDR

    Issued
    31 Jul 2026
    Expires
    23 Jan 2029
    Reason
    Add device or group

Related companies

Notified bodies

FDA recalls240

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Roche Diagnostics GmbH has initiated 240 recall records between September 30, 2002, and June 3, 2019, all of which are recorded as terminated. The reasons cited include inconsistencies in product uniformity, potential reagent contamination or misapplication leading to incorrect test results, calibration failures, software bugs affecting pipetting or calibration, reagent carryover effects, reagent splattering, sample mismatches due to software limitations, and issues with quality control recovery in assays. Complaints regarding improper use of sample tubes and inadequate manufacturing controls were also noted.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 240 recalls.

  • 2019

    • 3 Jun 2019 Z-1979-2019 Class II Terminated Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.
    • 4 Apr 2019 Z-1927-2019 Class III Terminated There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
    • 4 Apr 2019 Z-1928-2019 Class III Terminated There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
    • 18 Mar 2019 Z-1194-2019 Class II Terminated The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
    • 15 Mar 2019 Z-1249-2019 Class II Terminated The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment.
    • 4 Feb 2019 Z-1368-2019 Class II Terminated Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.

  • 2018

    • 17 Dec 2018 Z-0784-2019 Class II Terminated Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrepant result reporting may result.
    • 17 Dec 2018 Z-1145-2019 Class II Terminated New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***
    • 17 Dec 2018 Z-1146-2019 Class II Terminated New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***
    • 17 Dec 2018 Z-1147-2019 Class II Terminated New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***
Show the 25 most recent of 240 recalls

  • 2018

    • 14 Dec 2018 Z-1124-2019 Class II Terminated COBAS INTEGRA 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
    • 14 Dec 2018 Z-1125-2019 Class II Terminated COBAS INTEGRA 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over
    • 24 Sep 2018 Z-0301-2019 Class II Terminated Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on the Urisys 1100 urine analyzer with Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA test strips were higher than what is listed in the test strip method sheets may lead to false negative results for the affected parameters
    • 13 Sep 2018 Z-0360-2019 Class I Terminated Abnormally high INR test results with the affected CoaguChek test strips
    • 16 Jul 2018 Z-2944-2018 Class II Terminated Sample material may potentially come in contact with the pipetting nozzle during operation of cobas p 612 pre-analytical system (63x) (LCP1) with non-filter tips. The possible presence of biological material on the nozzle may cause contamination resulting in potential false positive results, depending on the sensitivity of the analytical technology.
    • 27 Apr 2018 Z-2389-2018 Class II Terminated The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.
    • 27 Apr 2018 Z-2390-2018 Class II Terminated The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.
    • 3 Apr 2018 Z-2136-2018 Class II Terminated The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.
    • 22 Feb 2018 Z-1610-2018 Class II Terminated The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
    • 22 Feb 2018 Z-1611-2018 Class II Terminated The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
    • 22 Feb 2018 Z-1612-2018 Class II Terminated The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
    • 22 Feb 2018 Z-1613-2018 Class II Terminated The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
    • 2 Jan 2018 Z-1519-2018 Class II Terminated The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/800/800 CTS analyzers and the MODULAR ANALYTICS P module are missing the following statement in the Limitations-interference section: "In very rare cases, gammopathy, in particular type IgM (Waldenstrm s macroglobulinemia), may cause unreliable results."

  • 2017

    • 22 Dec 2017 Z-1311-2018 Class II Terminated Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.
    • 18 Dec 2017 Z-1268-2018 Class II Terminated Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters.

About

As a pioneer in healthcare, we have been committed to improving lives since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally.

From the manufacturer's own website. Source

What Roche Diagnostics GmbH makes

Roche Diagnostics GmbH manufactures in vitro diagnostic (IVD) reagents and systems, including monoclonal antibodies for immunohistochemistry (e.g., anti-PMS2), immunoassays for tumor markers like alpha-fetoprotein (AFP) and calcitonin, and automated analyzers for measuring biomarkers such as CA 125 and ferritin. The portfolio also includes self-testing devices for blood glucose monitoring, such as infusion sets and portable coagulation analyzers for point-of-care testing.

The company’s products are regulated as Class I, Class II, and Class C medical devices, as well as IVD devices for self-testing, and are listed in the EU’s eudamed registry, the FDA’s 510(k) and PMA submissions. The manufacturer is based in Germany.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
Germany
Address
116 , Sandhofer Str. , Mannheim , Germany
Website
www.roche.com
PRRC contact
Anja Nedkov
EUDAMED SRN
DE-MF-000006260
FDA FEI number
3002806559
DUNS number
315028860