Products Recalled by Roche Diagnostics Ltd.

Starting date:

November 2, 2012

Posting date:

November 26, 2012

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public (GP), Healthcare Professionals, Hospitals

Identification number:

RA-15914

• Reason
• Affected products

Recalled Products

1. ALP2 (Alkaline Phosphatase AC. To IFCC Gen.2)
2. CO2-L (Bicarbonate Liquid) for Cobas C701 Analyzer
3. CREP2 (Creatinine Plus Ver.2) for Cobas C701 Analyzer
4. CRPL3 (C-Reactive Protein Gen.3) for Cobas C701 Analyzer
5. Ureal (Urea/Bun) for Cobas C701 Analyzer
6. ALT (Alanine Aminotransferase) IFCC"

Reason

Due to a software issue on the Cobas 8000 Analyzer, a mismatch between the reagent probe positioning on the Cobas C701 and C702 Analyzers and the aspirated reagent volumes may occur under certain high throughput conditions. This may lead to partial air pipetting at the end of the Cobas C Pack large, possibly affecting patient sample and control recovery.

Affected products