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COBAS INTEGRA TINA-QUANT HA1C GEN.2 and COBAS C 111 A1C-2 (2016-10-06)
- Starting date:
- October 6, 2016
- 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-60682
Affected Products
A. COBAS INTEGRA TINA-QUANT HA1C GEN.2
B. COBAS C 111 A1C-2
Reason
This recall/product correction is related to a potential over-recovery of the quality control materials and patient samples for the TINA-QUANT HBA1C GEN.2 due to freezing storage temperature.
Affected products
A. COBAS INTEGRA TINA-QUANT HA1C GEN.2
Lot or serial number
All lots.
Model or catalog number
04528123190
05401640190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. COBAS C 111 A1C-2
Lot or serial number
All lots.
Model or catalog number
Not Applicable
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY