Roche Diagnostics Operations recalls
8 official recalls and safety alerts involving Roche Diagnostics Operations since 2021-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Roche Diagnostics Operations or the relevant agency.
- 2026-03-11
USRoche Diagnostics Operations, Inc. recalls cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001…
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,…
- 2026-01-14
- US
Roche Diagnostics Operations, Inc. recalls The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and…
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.
FDA · DeviceRoche Diagnostics Operations, Inc.US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, ME, MI,…Official notice → - 2024-11-27
- US
Roche Diagnostics Operations, Inc. recalls cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total…
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
FDA · DeviceRoche Diagnostics Operations, Inc.US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,Official notice → - 2024-10-02
- US
Roche Diagnostics Operations, Inc. recalls Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination…
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.
- 2023-11-29
- US
Roche Diagnostics Operations, Inc. recalls Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311,…
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
- 2023-01-18
- US
Roche Diagnostics Operations, Inc. recalls cobas infinity central lab, Material Number 07154003001
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…
FDA · DeviceRoche Diagnostics Operations, Inc.Domestic distribution nationwide. Foreign distribution pending.Official notice → - 2022-08-17
- US
Roche Diagnostics Operations, Inc. recalls cobas e801 Immunoassay Analyzer
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…
FDA · DeviceRoche Diagnostics Operations, Inc.US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - 2021-11-24
- US
Roche Diagnostics Operations, Inc. recalls Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the…
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.