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cobas IT Middleware (2014-11-24)
- Starting date:
- November 24, 2014
- Posting date:
- December 11, 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-42793
Recalled Products
cobas IT Middleware
Reason
There is a potential issue between the cobas IT Middleware (cITM) system and customer laboratory information system (LIS) when spaces are used in the sample ID's. If the LIS sends sample ID with leading spaces to cITM this ID will be saved with spaces, when an instrument sends results back to cITM, since the driver removes these spaces during the transmission, therefore sample ID not found or wrong sample ID association may occur.
Affected products
cobas IT Middleware
Lot or serial number
All Versions
Model or catalog number
06498027001
06498035001
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY