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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 1–20 of 970 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.

High

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

Hemochron Activated Clotting Time Low-Range Test Cuvette,... (Accriva Diagnostics, Inc.) – foreign object (2025)

Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.

Moderate

FDANov 5, 2025Nationwide• Accriva Diagnostics, Inc.

BioFire Respiratory Panel 2.1 (BioFire) – False Negative Risk (2025)

Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.

12 3...49

Page 1 of 49Next

Moderate

FDAOct 22, 2025Nationwide• BioFire Diagnostics, LLC

VerifyNow PRUTest (Accriva) – Unauthorized Device Distribution (2025)

Due to an device without a premarket clearance being incorrectly package and distributed.

Moderate

FDAOct 21, 2025Nationwide• Accriva Diagnostics, Inc.

IMMULITE 2000 Oak Mix Allergen (Siemens) – barcode scanning error (2025)

The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.

Low

FDAOct 6, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

3gAllergy IgE Kit (Siemens) – barcode scanning error (2025)

Low

FDAOct 6, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Food Panel 3 Allergen (Siemens) – barcode scanning error (2025)

Low

FDAOct 6, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

OC-Auto FOBT-CHEK Controls (Polymedco) – labeling error (2025)

A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be 2027-01-17.

Low

FDAOct 6, 2025AL, AK, AZ +44 more• POLYMEDCO, INC. POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC

IMMULITE 2000 PTH Assay (Siemens) – result inaccuracy (2025)

The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.

Moderate

FDASep 22, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

STA Liatest D-Di (Diagnostica Stago) – D-Dimer Level Underestimation (2025)

A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.

Moderate

FDASep 12, 2025Nationwide• Diagnostica Stago, Inc.

Atellica CH Protein Test (Siemens) – false result risk (2025)

Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.

Low

FDAAug 11, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Chemistry LAC Slides (Ortho) – calibration failure (2025)

VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.

Moderate

FDAJul 29, 2025Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS Chemistry LAC Slides (Ortho) – calibration failure (2025)

Moderate

FDAJul 29, 2025Nationwide• Ortho-Clinical Diagnostics, Inc.

STA-Fibrinogen 5 (Diagnostica Stago) – Contamination Risk (2025)

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

Moderate

FDAJul 21, 2025Nationwide• Diagnostica Stago, Inc.

STA-Liquid Anti-Xa 8 (Diagnostica Stago) – Contamination Risk (2025)

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

Moderate

FDAJul 21, 2025Nationwide• Diagnostica Stago, Inc.

STA-Liquid Anti-Xa 4 (Diagnostica Stago) – Contamination Risk (2025)

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

Moderate

FDAJul 21, 2025Nationwide• Diagnostica Stago, Inc.

STA Satellite (Diagnostica Stago) – Contamination Risk (2025)

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

Moderate

FDAJul 21, 2025Nationwide• Diagnostica Stago, Inc.

Sucralfate Tablets (Nostrum Laboratories) – Quality Program Disruption (2025)

CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

Class IIModerate

FDAJul 11, 2025Nationwide• Nostrum Laboratories, Inc.

VITROS Chemistry Ca Slides (Ortho-Clinical) – Calibration Error (2025)

Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention.

Moderate

FDAJul 9, 2025Nationwide• Ortho-Clinical Diagnostics, Inc.

epoc BGEM BUN Test Card (Siemens) – Sodium Bias (2025)

Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/L, which occurred at a higher sodium concentration around 150 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.

Moderate

FDAJul 7, 2025Nationwide• Siemens Healthcare Diagnostics Inc