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Cobas Integra and Cobas C701 Total Protein Gen.2 (Tp2) (2017-07-05)
- Starting date:
- July 5, 2017
- Posting date:
- August 14, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-64114
Affected Products
- Cobas Integra Total Protein Gen.2 (Tp2)
- Tp2 (Total Protein Gen.2) For Cobas C701 Analyzer
Reason
The hemolysis serum index claim of 1000 for Total Protein Gen.2 which is mentioned in the method sheet cannot be met on Cobas C 311, 501, 502, 701, 702.
Affected products
A. Cobas Integra Total Protein Gen.2 (Tp2)
Lot or serial number
All lots
Model or catalog number
3183734190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. Tp2 (Total Protein Gen.2) For Cobas C701 Analyzer
Lot or serial number
All lots
Model or catalog number
5171385190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY