Roche Diagnostics
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Roche Diagnostics and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-03-11FDA-DeviceClass IIContact Roche about cobas pro analyzer software issue
Roche Diagnostics' cobas pro automated laboratory analyzer has a software defect that can cause it to accept incorrect calibrations. When this happens, the machine repeats the same result for multiple patient and quality-control tests instead of calculating new values, potentially leading to inaccurate lab results. This affects specific blood tests including ferritin, vancomycin, and light chain measurements.
- 2026-01-14FDA-DeviceClass IIContact your lab if you used Roche Elecsys Anti-TSHR
Roche Diagnostics has recalled certain lots of the Elecsys Anti-TSHR blood test due to inconsistent results across different laboratory instruments and variations between calibrator batches. These issues could lead to incorrect or delayed thyroid diagnosis and treatment.
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