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Cobas IT Middleware Core Unit (2015-04-01)
- Starting date:
- April 1, 2015
- Posting date:
- April 29, 2015
- 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-53133
Recalled products
- Cobas IT Middleware Core Unit
Reason
Cobas IT Middleware feature "sample closing" could fail if a "rebuilt sample" message was sent by the host before the "sample closing date" already established by the user. The sample result mismatch may occur, if the customer allows recycling patient's ids and if their system was set to allow "sample rebuild".
Affected products
A. Cobas IT Middleware Core Unit
Lot or serial number
All software versions.
Model or catalog number
- 06498027001
- 06498035001
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY