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cobas IT middleware (2014-11-25)
- Starting date:
- November 25, 2014
- Posting date:
- December 5, 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-42765
Recalled Products
cobas IT middleware
Reason
There is an issue on cobas IT middleware where the masking of tests function (block release) is not working for modules if the master instrument is selected, therefore a remote probability that a delay or incorrect initial diagnosis may occur.
Affected products
cobas IT middleware
Lot or serial number
version 1.02.00 and above
Model or catalog number
06498027001
06498035001
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY