Cobas (2020-12-16)
- Starting date:
- December 16, 2020
- Posting date:
- December 31, 2020
- 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-74687
Last updated: 2020-12-31
Affected Products
- Cobas 8000 Core Unit
- COBAS C 513 ANALYZER
- COBAS PRO SAMPLE SUPPLY UNIT
Reason
In very rare circumstances, a database timeout error can occur which affects the settings stored on the SQL server leading to a deactivation of some analyzer settings on Cobas 8000, Cobas C 513 and Cobas Pro Systems.
Affected products
A. Cobas 8000 Core Unit
Lot or serial number
All software versions.
Model or catalog number
- 5641446001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. COBAS C 513 ANALYZER
Lot or serial number
All software versions.
Model or catalog number
Not applicable.
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. COBAS PRO SAMPLE SUPPLY UNIT
Lot or serial number
- 1924-01
- 1924-02
Model or catalog number
Not applicable.
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY