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COBAS IT MIDDLEWARE (2016-08-18)
- Starting date:
- August 18, 2016
- Posting date:
- August 26, 2016
- 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-60002
Affected Products
COBAS IT MIDDLEWARE
Reason
During the investigation of an issue from a customer complaint, it was found by the manufacturer that the daily cleanup sample can fail in deleting samples which are older than the configured retention period in the cobas IT middleware. Some samples which have been ordered from the lis and remain with open tests may not be deleted. Open tests are those for which results did not complete the processing cycle, including transmission to lis.
Affected products
COBAS IT MIDDLEWARE
Lot or serial number
All software versions.
Model or catalog number
06498027001
06498035001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY