Roche Diagnostics Operations, Inc.
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Roche Diagnostics Operations, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-11-27FDA-DeviceClass IIcobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
- 2024-10-02FDA-DeviceClass IICreatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190
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.
- 2023-11-29FDA-DeviceClass IITina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
Get notified about new Roche Diagnostics Operations, Inc. recalls
Free weekly digest. We email when a new federal recall affects Roche Diagnostics Operations, Inc. or anything else in your household.
Get the Sunday Brief