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Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc. Recalls

All product recalls associated with Roche Diagnostics Operations, Inc..

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Recall Summary

Total Recalls

970

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 461–480 of 970 recalls

Roche Diagnostics Operations, Inc.: cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus ...

Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference

FDAAug 28, 2019Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: cobas c 701 and 702 Analyzer/Module-RF interference claim...

Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference

FDAAug 28, 2019Nationwide• Roche Diagnostics Operations, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19...

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

1...22 232425 26...49

Page 24 of 49Next

FDA

Aug 15, 2019

Nationwide

• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.1...

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

FDAAug 15, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc: Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material N...

Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be completed as defined in the aCCP Test Definition (TDef). The issue occurs on an Atellica IM Analyzer and is isolated to TDef Version 1.0. FOR OUS: Atellica IM anti-CCP IgG (aCCP) and Pregnancy-Associated Plasma Protein-A (PAPP-A) Test Definition (TDef) Mitigation Failure

FDAAug 14, 2019Nationwide• Siemens Healthcare Diagnostics, Inc

Roche Diagnostics Operations, Inc.: AssayTip/AssayCup Tray-used on the cobas e 801 module whi...

AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results

FDAAug 13, 2019Nationwide• Roche Diagnostics Operations, Inc.

BioFire Diagnostics, LLC: FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-010...

Complaints have been received concerning elevated rates of false negative results while using the Gastrointestinal (GI) Panel. False negative results may lead to incorrect treatment being provided which could potentially lead to more serious health events.

FDAAug 8, 2019IL, KY, MS +1 more• BioFire Diagnostics, LLC

Siemens Healthcare Diagnostics, Inc.: Siemens Atellica CH 930 Analyzer. Siemens Material Num...

Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below

FDAJul 30, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Roche Diagnostics Operations, Inc.: Online TDM Vancomycin Gen.3 (100 tests) Catalog # 067793...

Inaccurately Low Sample Results

FDAJul 23, 2019AL, AK, AZ +49 more• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779...

Inaccurately Low Sample Results

FDAJul 23, 2019AL, AK, AZ +49 more• Roche Diagnostics Operations, Inc.

Siemens Healthcare Diagnostics, Inc: Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of fo...

Homocysteine Assay May Cause Elevated Results in the Folate Assay

FDAJul 22, 2019Nationwide• Siemens Healthcare Diagnostics, Inc

Siemens Healthcare Diagnostics, Inc: Siemens ADVIA Centaur Folate 100 test kit-for IVD of fola...

Homocysteine Assay May Cause Elevated Results in the Folate Assay

FDAJul 22, 2019Nationwide• Siemens Healthcare Diagnostics, Inc

Aniara Diagnostica LLC: ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D...

Residual crystallization of the microplate and recurrent negative controls out of range.

FDAJul 19, 2019NH, NY, NC +1 more• Aniara Diagnostica LLC

Aniara Diagnostica LLC: ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, ...

Residual crystallization of the microplate and recurrent negative controls out of range.

FDAJul 19, 2019NH, NY, NC +1 more• Aniara Diagnostica LLC

Roche Diagnostics Operations, Inc.: cobas c513 Analyzer

Quality issue with high pressure solenoid valves

FDAJul 18, 2019AK, CA, FL +12 more• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: cobas e 601 module (cobas 6000 Modular Series system) Par...

Quality issue with high pressure solenoid valves may cause inaccurate results.

FDAJul 18, 2019AK, CA, FL +12 more• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Cobas 8000 Modular Analyzer Series: cobas 8000 ISE mod...

Quality issue with high pressure solenoid valves

FDAJul 18, 2019AK, CA, FL +12 more• Roche Diagnostics Operations, Inc.

Luminex Molecular Diagnostics: xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP...

The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and detecting RSV A in patient specimens. However, the assay will continue to detect Influenza A, Influenza B, RSV B and all other targets in accordance with each of these products performance claims.

FDAJul 16, 2019CA, CT, MA +1 more• Luminex Molecular Diagnostics

Roche Diagnostics Operations, Inc.: Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190

Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.

FDAJul 16, 2019AZ, CA, FL +19 more• Roche Diagnostics Operations, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Ferritin (FERR) Flex reagent cartridge DM FERR...

Negative Bias with Lot EA9227.

FDAJul 15, 2019AK, AZ, AR +32 more• Siemens Healthcare Diagnostics, Inc.