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AMMONIA NH3 (2015-10-08)
- Starting date:
- October 8, 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-56044
Affected Products
- HITACHI AMMONIA (NH3)
- COBAS INTEGRA CREATINE KINASE-MB (CKMBL)
- NH3L (AMMONIA) ASSAY KIT FOR COBAS C111
- GLDH (GLUTAMATE DEHYDROGENASE)
-
NH3L (AMMONIA) FOR COBAS C701 ANALYZER
Reason
The interference of temozolomide was investigated and confirmed at very low analyte or too high drug concentrations.
Affected products
A. HITACHI AMMONIA (NH3)
Lot or serial number
All lots.
Model or catalog number
04525299190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. COBAS INTEGRA CREATINE KINASE-MB (CKMBL)
Lot or serial number
All lots.
Model or catalog number
11929992216
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. NH3L (AMMONIA) ASSAY KIT FOR COBAS C111
Lot or serial number
All lots.
Model or catalog number
11877984216
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
D. GLDH (GLUTAMATE DEHYDROGENASE)
Lot or serial number
All lots.
Model or catalog number
20766682322
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
E. NH3L (AMMONIA) FOR COBAS C701 ANALYZER
Lot or serial number
All lots.
Model or catalog number
05975581190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY