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Cobas 8000 E602 Immunoassay Analyzer
- Starting date:
- March 8, 2017
- Posting date:
- March 31, 2017
- 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-62838
Reason
Following internal investigation of customer complaints, the manufacturer identified a situation where when the Cobas 8000-E602 analyzer was running SW versions 05-01, 05-02 and 06-02, the system may behave incorrectly after deleting an immunoassay application while the corresponding reagent pack is still onboard of the Cobas E602.
Affected products
Cobas 8000 E602 Immunoassay Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
05990378001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY