Multiple Chemistry Assays by Roche Diagnostics (2015-05-12)

Starting date:

May 12, 2015

Posting date:

August 19, 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-54674

• Reason
• Affected products

Affected products

1. HITACHI TRIGLYCERIDES GPO-PAP (TG)
2. HITACHI GLUCOSE (GOD-PAP)
3. COBAS INTEGRA TRIGLYCERIDES (TRIGL)
4. COBAS INTEGRA CHOLESTEROL GEN.2 (CHOL2)
5. COBAS INTEGRA URIC ACID VER.2 (UA2)
6. COBAS INTEGRA CREATININE PLUS VER.2 (CREP2)
7. HITACHI URIC ACID PLUS (UA PLUS)
8. HITACHI CREATININE PLUS (CREA PLUS)
9. HITACHI TRIGLYCERIDES/GLYCEROL BLANKED(GB)
10. HITACHI LDL-CHOLESTEROL, NO PRETREATMENT, LDL-C P
11. HITACHI LDL-C PLUS
12. HITACHI CHOLESTEROL CHOD-PAP (CHOL)
13. HITACHI HDL-C PLUS, 3RD GENERATION
14. COBAS C/INTEGRA HDL-C GEN. 3
15. COBAS C 111 HDL-CHOLESTEROL PLUS
16. COBAS C 111 TRIGLYCERIDES (TRIGL)
17. COBAS C 111 LDL-CHOLESTEROL (LDL_C)
18. COBAS C 111 URIC ACID (UA2)
19. COBAS C 111 CHOLESTEROL (CHOL2)
20. COBAS C 111 CREP2 - CREATININE PLUS
21. HITACHI LACTATE
22. COBAS INTEGRA LACTATE GEN.2 (LACT2)
23. LACTATE GEN.2 FOR COBAS C111
24. HDLC3 (HDL-CHOLESTEROL PLUS 3RD GENERATION) FOR C
25. CREP2 (CREATININE PLUS VER.2) FOR COBAS C701 ANAL
26. LDL-C (LDL-CHOLESTEROL PLUS 2ND GENERATION) FOR C
27. UA2 (URIC ACID VER.2) FOR COBAS C701 ANALYZER
28. TRIGL (TRIGLYCERIDES) FOR COBAS C701 ANALYZER
29. CHOL2 (CHOLESTEROL GEN.2)
30. TRIGB (TRIGLYCERIDES/GLYCEROL BLANKED) FOR COBAS
31. LACT2 (LACTATE GEN.2) FOR COBAS C701 ANALYZER

Reason

During and internal investigation, it was found that multiple chemistry assays are showing possible interference with acetaminophen metabolite (NAPQI) and acetaminophen antidote (NAC). This could cause falsely low results recovery under certain rare circumstances where a patient would show a specific medical condition combined with a high level of medication.

Affected products