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Cobas IT Middleware (2014-05-29)
- Starting date:
- May 29, 2014
- Posting date:
- June 24, 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-40195
Recalled products
- Cobas IT Middleware
Reason
The Cobas IT Middleware Data Manager System could display a wrong result record after creating samples and entering results manually.
Affected products
A. 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