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COBAS 8000 DATA MANAGER (2015-05-22)
- Starting date:
- May 22, 2015
- Posting date:
- July 7, 2015
- 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-54010
Recalled Product
A. COBAS 8000 DATA MANAGER
Reason
Potential issue with the Cobas 8000 data manager system (all versions) where the option "automatic patient masking when QC error" option does work correctly. This functionality does not work if the results for the last measured control level for this test is valid. As a consequence, the results for the measured samples would not be released and forwarded to host due to the QC error.
Affected products
A. COBAS 8000 DATA MANAGER
Lot or serial number
N/A
Model or catalog number
- 6888160001
- 7267657001
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY