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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

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 861–880 of 970 recalls

Roche Diagnostics Corp.: Roche CoaguChek S System Controls; Catalog number 3033384...

Laceration Risk

Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.

FDAMar 28, 2005Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche CoaguChek System Controls (patient self testing); C...

Laceration Risk

Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.

FDAMar 28, 2005Nationwide• Roche Diagnostics Corp.

Nichols Institute Diagnostics: Nichols IRMA Intact PTH Assay, catalog No. 40-2171

Firm noted a change in performance and therefore changed the labeled performance specifications in the Directional Insert portion of the labeling.

1...42 434445 46...49

Page 44 of 49Next

FDAMar 25, 2005Nationwide• Nichols Institute Diagnostics

Ortho-Clinical Diagnostics: VITROS Immunodiagnostic Products TOTAL T4 REAGENT PACK, R...

Potential for positively biased results in QC and patient samples.

FDAMar 15, 2005Nationwide• Ortho-Clinical Diagnostics

Trek Diagnostic Systems: Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles,...

Blood culture bottles with an error in the bar code on the labels, were shipped.

FDAMar 4, 2005FL, GA, IL +15 more• Trek Diagnostic Systems

Roche Diagnostics Corp.: Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyze...

The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.

FDAFeb 15, 2005Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyze...

The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.

FDAFeb 15, 2005Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGR...

The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.

FDAFeb 15, 2005Nationwide• Roche Diagnostics Corp.

Roche Diagnostics Corp.: BioTek brand Automated Microplate Reader; model ELx800, R...

The parameters loaded in the analyzer for the hepatitis C virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives.

FDAFeb 15, 2005Nationwide• Roche Diagnostics Corp.

Diagnostic Products Corp: IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, ...

A low CPS limit was not incorporated in the kit barcode for IMMULITE 2000 Vitamin B12 L2KVB 2, 6 kit lot 186 only.

FDAJan 24, 2005AL, CA, CO +19 more• Diagnostic Products Corp