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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 321–340 of 475 recalls

Roche Diagnostics Operations, Inc.: Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Nu...

Due to low Quality Control recovery and invalid Calibration.

FDASep 11, 2019Nationwide• Roche Diagnostics Operations, Inc.

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

FDA

1...15 161718 19...24

Page 17 of 24Next

Aug 28, 2019

Nationwide

• 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

FDAAug 15, 2019Nationwide• 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.

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

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 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.

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.: 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.

Siemens Healthcare Diagnostics, Inc.: IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128

There is a potential for low discordant progesterone results on a subset of patient samples. A falsely low progesterone result may lead to the consideration for additional progesterone supplementation.

FDAJul 10, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and...

FDAJul 10, 2019Nationwide• Siemens Healthcare Diagnostics, Inc.

Roche Diagnostics Operations, Inc.: The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno...

The firm conducted internal investigations that confirmed customer complaints of quality control (QC) imprecision and calibration failures for the Tina-quant Myoglobin Gen.2 assay (catalog number 04580010190), lot number 349860 on the cobas c311 analyzer and cobas c501 and c502 modules due to a drop in signal in the reaction kinetics. This signal drop was traced to an adjacent cell mixing effect. Sample recovery is decreased as a consequence of the disturbance in reaction kinetics. The investigation found discrepancies of up to -30%. Calibration, QC, and patient samples can be affected. The following issues were reported: - Calibration failures; Dup.E error due to signal drop in reaction kinetics - Sporadic quality control (QC) imprecision. As a long-term solution, the firm will implement required extra wash cycles (EWCs) into the respective Special Wash Requirements method sheets for the cobas c 311 analyzer and cobas c 501 and 502 modules, and into the cobas e-file for the cobas c 502 module. For the use of the reagent with the cobas c501 and c502, Roche will also direct users to run the Tina-Quant Myoglobin gen. 2 assay independently from other tests, in a batch mode status, with a maximum of 39 samples per run. Additionally, a change in the application settings of the Tina-quant Myoglobin Gen.2 assay on the cobas c 501 and 502 modules will be implemented so that adjacent cuvettes are no longer used in order to prevent adjacent cell mixing effects. The application settings change will be communicated at a later date.

FDAJul 2, 2019Nationwide• Roche Diagnostics Operations, Inc.