Roche Diagnostics Operations, Inc. Recalls

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

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Recall Summary

Total Recalls

13

Past Year

1

Class I (Serious)

0

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 1–13 of 13 recalls

The Elecsys Anti-TSHR immunoassay is a three-step competi... (Roche Diagnostics Operations, Inc.) – issues identified: 1) results vary by... (2025)

Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.

Moderate

FDANov 21, 2025Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: cobas HCYS, Homocysteine Enzymatic Assay, Material Number...

Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)

Moderate

FDAOct 17, 2024FL, IN, IA +5 more• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Creatine Kinase (CK) used on cobas c 311/501/502 and COBA...

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.

Moderate

FDAAug 15, 2024Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degrada...

Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.

Moderate

FDAOct 3, 2023Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: cobas infinity central lab, Material Number 07154003001

A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the LIS. The erroneous event occurs under rare circumstances where the date in the sample's barcode does not match the order date sent from the LIS, and can lead to the order being mismatched to an another patient's sample ID rather than the subject patient's sample ID. The software bug impacts multiple cobas infinity central lab software (versions 2.5.x , 3.01.x, 3.02.x, and 3.03.x) and occurs when the afflicted software has been configured with specific pre-conditions.

Moderate

FDADec 12, 2022Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: cobas e801 Immunoassay Analyzer

Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the issue: Anti-HAV2, Anti-HBc IgM, IGF-1, Myogloin, Rubella IgG, and Toxo IgG.

Moderate

FDAJul 14, 2022Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETT...

Roche received several complaints regarding increased control recovery and discrepant elevated results for the Iron Gen.2 (IRON2) assay on the cobas c311, 501, and 502 analyzers and on the COBAS Integra 400 plus analyzer.

Moderate

FDAApr 26, 2021Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Pr...

Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.

Moderate

FDAApr 7, 2021Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160...

Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.

Moderate

FDAApr 7, 2021Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Roche cobas pro integrated solutions (cobas pro ISE, coba...

Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.

Moderate

FDADec 8, 2020Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Roche cobas 8000 modular analyzer series (i.e., cobas 800...

Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.

Moderate

FDADec 8, 2020Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: DISCOVERY ULTRA Advanced Staining System (RUO-Research Us...

Fire/Burn Risk

Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket

Moderate

FDAAug 31, 2020Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: BenchMark ULTRA Advanced Staining System (IVD)- Material ...

Fire/Burn Risk

Potential for Fluid leaks within the instruments, creating an electrical short inside the power socket, which generates heat, smoke, and eventually burning and melting of the electrical cord connector and socket

Moderate

FDAAug 31, 2020Nationwide• Roche Diagnostics Operations, Inc.

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Roche Diagnostics Operations, Inc. Recalls

Recall Summary

The Elecsys Anti-TSHR immunoassay is a three-step competi... (Roche Diagnostics Operations, Inc.) – issues identified: 1) results vary by... (2025)

Roche Diagnostics Operations, Inc.: cobas HCYS, Homocysteine Enzymatic Assay, Material Number...

Roche Diagnostics Operations, Inc.: Creatine Kinase (CK) used on cobas c 311/501/502 and COBA...

Roche Diagnostics Operations, Inc.: Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degrada...

Roche Diagnostics Operations, Inc.: cobas infinity central lab, Material Number 07154003001

Roche Diagnostics Operations, Inc.: cobas e801 Immunoassay Analyzer

Roche Diagnostics Operations, Inc.: IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETT...

Roche Diagnostics Operations, Inc.: Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Pr...

Roche Diagnostics Operations, Inc.: Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160...

Roche Diagnostics Operations, Inc.: Roche cobas pro integrated solutions (cobas pro ISE, coba...

Roche Diagnostics Operations, Inc.: Roche cobas 8000 modular analyzer series (i.e., cobas 800...

Roche Diagnostics Operations, Inc.: DISCOVERY ULTRA Advanced Staining System (RUO-Research Us...

Roche Diagnostics Operations, Inc.: BenchMark ULTRA Advanced Staining System (IVD)- Material ...