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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

475

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 241–260 of 475 recalls

Roche Diagnostics Operations, Inc.: CoaguChek XS PST Meters- IVD (Patient Self-Testing) measu...

Possible Misinterpretation of Displayed Measuring Units from INR to %Quick or Seconds; providing instructions to users for ensuring the meter is displaying INR results

FDADec 2, 2020Nationwide• Roche Diagnostics Operations, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH 930 Analyzer - In vitro diagnostic testing of...

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

FDADec 2, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1600 Analyzer - In vitro diagnostic testing o...

Multiple issues in Software v1.23.2 and lower-may lead to the reporting of discrepant patient results

FDA

1...11 121314 15...24

Page 13 of 24Next

Dec 2, 2020

Nationwide

• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product ...

Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reagent may demonstrate a coefficient of variation (%CV) outside of the performance data for repeatability (within-run) listed in the Instructions For Use (IFU) on some analyzers.

FDANov 23, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Roche Diagnostics Operations, Inc.: cobas pro integrated solutions -cobas c 503, Analyzer, ch...

During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring).

FDANov 23, 2020FL, GA, IL +1 more• Roche Diagnostics Operations, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Produ...

FDANov 23, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS Automation Solutions, VAS, Catalog Numbers 6844300...

A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient.

FDANov 20, 2020Nationwide• Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc.: enGen Laboratory Automation System, enGen Track System, C...

FDANov 20, 2020Nationwide• Ortho-Clinical Diagnostics, Inc.

Roche Diagnostics Operations, Inc.: Tina-quant C-Reactive Protein Gen.3, Catalog number 05172...

Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.

FDANov 6, 2020Nationwide• Roche Diagnostics Operations, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1600 Analyzer - Product Usage: automated, imm...

Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values

FDAOct 26, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica IM 1300 Analyzer - Product Usage: automated, imm...

Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values

FDAOct 26, 2020Nationwide• Siemens Healthcare Diagnostics, Inc.

Ortho Clinical Diagnostics Inc: VITROS Chemistry Products Performance Verifier II-For in ...

Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

FDAOct 16, 2020Nationwide• Ortho Clinical Diagnostics Inc

Roche Diagnostics Operations, Inc.: cobas infinity central lab/cobas infinity core license-Th...

Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule

FDAOct 9, 2020Nationwide• Roche Diagnostics Operations, Inc.

Epitope Diagnostics, Inc.: EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-103...

The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.

FDAOct 1, 2020CA, CO, FL +17 more• Epitope Diagnostics, Inc.

Ortho Clinical Diagnostics Inc: VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrato...

Laceration Risk

Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control

FDASep 30, 2020Nationwide• Ortho Clinical Diagnostics Inc

Siemens Healthcare Diagnostics, Inc.: Atellica CH Systems Fructosamine (FRUC)-For in vitro diag...

Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.

FDASep 22, 2020CA, DE, MD +4 more• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro ...

FDASep 22, 2020CA, DE, MD +4 more• Siemens Healthcare Diagnostics, 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

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

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

Fire/Burn Risk

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

Siemens Healthcare Diagnostics Inc: Siemens epoc BGEM Test Card-In vitro diagnostic device fo...

Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia.

FDAAug 28, 2020Nationwide• Siemens Healthcare Diagnostics Inc