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Immunoglobulin G for Cobas Integra Analyzers
- Starting date:
- December 14, 2012
- Posting date:
- January 21, 2013
- 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-16901
Recalled Products
- Immunoglobulin G for Cobas Integra Analyzers
Reason
The reason for the recall is related to a possible carry-over from serum into Cerebrospinal fluid (CSF) samples for Immunoglobulin G that may lead to an increase of a CSF test result by up to 70 pourcent on Cobas Integra 800 analyzer.
Affected products
A. Immunoglobulin G for Cobas Integra Analyzers
Lot or serial number
All Lots.
Model or catalog number
20766631322
Companies
- Manufacturer
- Roche Diagnostics GMBH