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ALB2 (Albumin Gen. 2) for Cobas C701 Analyzer
- Starting date:
- October 3, 2012
- Posting date:
- October 29, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15163
Recalled Products:
ALB2 (Albumin Gen. 2) for Cobas C701 Analyzer
Reason
Is related to a possible issue where patient and quality control albumin results may become erratic over time with a continuous throughput of more than 300 tests in a shift with deviations of up to 10%.
Affected products
ALB2 (Albumin Gen. 2) for Cobas C701 Analyzer
Lot or serial number
All lots
Model or catalog number
05166861190
Companies
- Manufacturer
- Troche Diagnostics Ltd.