Roche Diagnostics Operations, Inc.: Medical Device Recalls in 2019

According to to data from the FDA, there were 15 medical device recalls made by Roche Diagnostics Operations, Inc. in 2019. See the details of the recalls below.

You can see similar recalls for other firms.

• Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190 - - Product Usage: The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.
• cobas c513 Analyzer
• The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers
• Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190
• Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
• AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
• cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
• cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122
• Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
• Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
• Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001
• Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
• cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190
• Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
• Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.