Roche Diagnostics Operations, Inc. recalls

4 recalls on record · latest: January 20, 2026

Official U.S. recall history for Roche Diagnostics Operations, Inc., compiled from official government records.

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Roche Diagnostics Operations, Inc. recalls cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 0846450…

January 20, 2026 · Medical device recalls Moderate risk Software defect, which allows the system to accept erroneous, non-monotonous ca…

Roche Diagnostics Operations, Inc. recalls The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and e…

November 21, 2025 · Medical device recalls Moderate risk Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to…

Roche Diagnostics Operations, Inc. recalls cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test fo…

October 17, 2024 · Medical device recalls Moderate risk Abnormal calibration signals and control recovery issues on the Homocysteine En…

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 determin…

August 15, 2024 · Medical device recalls Moderate risk Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 an…