MULTIPLE CHEMISTRY ASSAYS BY ROCHE DIAGNOSTICS (2015-06-23)

Starting date:

June 23, 2015

Posting date:

August 11, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-54630

• Reason
• Affected products

Affected Products

1. HITACHI AST ACC. TO IFCC W/WO PYRIDOXAL PHOSPHATE ACTIVATION (ASAT/GOT)
2. COBAS INTEGRA ALANINE AMINOTRANSFERASE (ALTL)
3. COBAS INTEGRA ASPARTATE AMINO.(ASTPL) PYRIDOXAL PHOS. ACTIVATED LiQUID REA
4. HITACHI AMMONIA (NH3)
5. COBAS INTEGRA CREATINE KINASE-MB (CKMBL)
6. HITACHI CREATININE KINASE-MB LIQUID (CK-MB)
7. HITACHI ALANINE AMINO. TO IFCC W/WO PYRIDOXAL PHOSPHATASE ALT (ALAT/GPT)
8. COBAS INTEGRA ALTLP
9. 42181
10. COBAS C 111 ASPARTATE AMINOTRANSFERASE W/ OR W/O PYRIDOXAL PHOSPHATE ACTIV
11. COBAS C 111 ALANINE AMINOTRANSFERASE W/ OR W/O PYRIDOXAL PHOSPHATE ACTIV.
12. COBAS INTEGRA AMMONIA (NH3)
13. GLDH (GLUTAMATE DEHYDROGENASE)
14. ASTPM(ASPARTATE AMINOTRANSF.) W PYRIDOXAL PHOSPHATE ACTIVAT. FOR COBAS C701
15. NH3L (AMMONIA) FOR COBAS C701 ANALYZER
16. AST (ASPARTATE AMINOTRANSFERASE) IFCC FOR COBAS C701 ANALYZER
17. ALT (ALANINE AMINOTRANSFERASE) IFCC

Reason

The manufacturer has identified during an internal investigation that multiple Chemistry Assays (alanine, aspartate, creatine kinase-mb, and glutamate dehydrogenase and ammonia test kits) are showing possible interference with patient samples containing a certain amount of sulfasalazine/sulfapyridine.

Affected products