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CERULOPLASMIN FOR ROCHE/HITACHI COBAS C ANALYZERS
- Starting date:
- September 6, 2016
- 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-60436
Affected Products
Reason
It was determined that discrepant results in patient samples, internal quality controls (ICQ) and external quality assessment (EAQ) samples may be obtained for ceruloplasmin assay of specific lots used on Roche Cobas c Analyzers.
Affected products
CERULOPLASMIN FOR ROCHE/HITACHI COBAS C ANALYZERS
Lot or serial number
- 157353
- 621629
Model or catalog number
- 20764663322
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY