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Roche Diagnostics Corp.

Roche Diagnostics Corp. Recalls

All product recalls associated with Roche Diagnostics Corp..

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Recall Summary

Total Recalls

970

Past Year

46

Class I (Serious)

16

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 661–680 of 970 recalls

Roche Diagnostics Corp.: Roche/Hitachi Modular E Module immunoassay analyzer, Roch...

A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly.

FDAJun 24, 2008Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INT...

Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

FDAJun 11, 2008Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS IN...

Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

FDAJun 11, 2008Nationwide

1...32 333435 36...49

Page 34 of 49Next

• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generat...

Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

FDAJun 11, 2008Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, coba...

Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

FDAJun 11, 2008Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd genera...

Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

FDAJun 11, 2008Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche Diagnostics ALBT2, Tina-quant Albumin Gen. 2, COBAS...

Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

FDAJun 11, 2008Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche Diagnostics STFR Tina-quant Soluble Transferrin Rec...

Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

FDAJun 11, 2008Nationwide• Roche Diagnostics Corp.

Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila: AxSYM Digoxin II Reagent Pack, Disk Version 1. (3D53-01 o...

AxSYM TDM/ Transplant Assay Disks 3D53-03 and higher do not contain the AxSYM Digoxin II Assay file. The instrument might require installation of the AxSYM Digoxin II assay file.

FDAMay 22, 2008AL, AZ, AR +25 more• Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila

Siemens Medical Solutions Diagnostics: COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device i...

The field action was initiated after the firm confirmed that the Coat-A-Count PSA IRMA kit (IKPS1, 2, 5, X) exhibits a low bias, which is evident when comparing results with other methods, including the IMMULITE PSA kits. Coat-A-Count PSA IRMA results are, for example, approximately 20% lower when compared to results obtained with the IMMULITE 2000 Third Generation PSA assay (L2KUP).

FDAMay 21, 2008Nationwide• Siemens Medical Solutions Diagnostics

Siemens Healthcare Diagnostics, Inc.: Siemens Stratus CS Acute Care Troponin I CalPak. In vitr...

The firm received and confirmed that some lots of Cardiac Troponin I (cTnl) CalPaks (CCTNI-CR) may exhibit calibration issues that cause lower than typical signal during calibration with the current population of cTnl TestPaks (CCTNI). This issue may result in failed calibrations due to "Slope Error" messages or falsely elevated patient sample and quality control (QC) results on calibrations that

FDAApr 28, 2008Nationwide• Siemens Healthcare Diagnostics, Inc.

Nerl Diagnostics LLC: S/P Orange 50g Glucose Tolerance Beverage, 10 oz glass bo...

Beverage may contain glass particles.

FDAApr 23, 2008Nationwide• Nerl Diagnostics LLC

Siemens Healthcare Diagnostics, Inc.: Dimension Flex Reagent Cartridge C-Reactive Protein Exten...

falsely elevated results in EDTA plasma samples

FDAApr 15, 2008Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.: Dimension Cardiac Troponin I Flex reagent cartridge (CTN...

possibility of falsely elevated results

FDAApr 8, 2008Nationwide• Siemens Healthcare Diagnostics, Inc.

Siemens Medical Solutions Diagnostics: In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test...

False negative hCG results due to decreased sensitivity

FDAApr 4, 2008Nationwide• Siemens Medical Solutions Diagnostics

Siemens Healthcare Diagnostics Inc.: Dimension Total Prostate Specific Antigen (TPSA) Flex Rea...

False Results: The product may exhibit falsely elevated results. The affected lots demonstrate sporadic variability in recovery of calibrator and quality control; therefore this issue may not be readily detected upon calibration or during routine processing of Quality Control.

FDAMar 24, 2008Nationwide• Siemens Healthcare Diagnostics Inc.

Roche Diagnostics Corp.: Roche/Hitachi Modular Analytics System, Modular D2400 Mod...

Possible mismatch between patient and result.

FDAMar 21, 2008Nationwide• Roche Diagnostics Corp.

Diagnostic Chemicals, Ltd.: Diagnostics Chemical Limited Iron Assay Catalog Number: ...

Precipitate in product may cause elevated background absorbance interference.

FDAMar 14, 2008Nationwide• Diagnostic Chemicals, Ltd.

Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila: AxSYM Ultrasensitive hTSH II Master Calibrators Micropar...

High Control value out of range after calibration. --AN INCREASED FREQUENCY OF HIGH CONTROL VALUES BEYOND THE UPPER LIMIT OF THE RANGE SPECIFIED BY THE PACKAGE INSERT.

FDAMar 6, 2008AZ, CA, CO +32 more• Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila

Nanosphere, Inc.: Warfarin Metabolism Nucleic Acid Test Cartridge; Part Num...

Aberrant Results: A warfarin 2C9*2 mutant capture signal was found to be high enough to result in an aberrant result (i.e., wild-type called heterozygous).

FDAFeb 25, 2008Nationwide• Nanosphere, Inc.