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Cobas 8000 - C502 Chemistry Analyzer (2014-03-27)
- Starting date:
- March 27, 2014
- Posting date:
- April 15, 2014
- 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-39089
Recalled products
- Cobas 8000 - C502 Chemistry Analyzer
Reason
The integrated cassette volume check (ICVC) is not automatically performed on the Cobas 80000-C502 Chemistry Analyzer for the Cobas C Pack Multi and for the Carbamazepine Carb3 for C311 and C501/502, due to ICVC being deactivated in the Rec file for these reagents.
Affected products
Cobas 8000 - C502 Chemistry Analyzer
Lot or serial number
Serial numbers:
- 1019-08
- 1019-10
- 1128-05
- 1140-04
- 1247-08
Model or catalog number
- 05964067001
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY