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Cobas E 411 Immunoassay Analyzer
- Starting date:
- July 7, 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, Hospitals
- Identification number:
- RA-64118
Reason
A potential software limitation in the Cobas E411 Immunoassay Analyzer could lead to a potential data mismatch under specific conditions.
Affected products
Cobas E 411 Immunoassay Analyzer
Lot or serial number
all software versions
Model or catalog number
- 04775201001
- 04775279001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY