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Anti-HAV Kit
- Starting date:
- February 9, 2017
- Posting date:
- February 28, 2017
- 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-62406
Reason
When Li-Heparin and Na-heparin plasma specimens were compared to serum samples during internal investigations, the specified required recovery could not be achieved. Therefore, the claim in the method sheet regarding acceptable specimens under 'specimen collection and preparation' will be corrected.
Affected products
Anti-HAV Kit
Lot or serial number
All lots
Model or catalog number
04854977190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY