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Cobas Analyzers (2017-07-13)
- Starting date:
- July 13, 2017
- Posting date:
- August 14, 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-64160
Affected Products
- Cobas 6000 - E601
- Modular Analytics E Combinations Analyzer (E170)
- Cobas 8000 E602 Immunoassay Analyzer
Reason
A sample mismatch may occur in the Immunochemistry Modules (Cobas E602, Cobas E601 and E170 Modules) due to a software limitation which can only occur in very rare occasion.
Affected products
A. Cobas 6000 - E601
Lot or serial number
All software versions
Model or catalog number
04745922001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. Modular Analytics E Combinations Analyzer (E170)
Lot or serial number
All software versions
Model or catalog number
04745922001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. Cobas 8000 E602 Immunoassay Analyzer
Lot or serial number
all software versions
Model or catalog number
03023109001
03023117001
03739040001
05023572001
05023599001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY