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COBAS C 111 and COBAS C 111 WITH ISE STAND ALONE CONFIGURATION (2016-10-05)
- Starting date:
- October 5, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Hospitals, General Public, Healthcare Professionals
- Identification number:
- RA-60684
Affected Products
A. COBAS C 111 STAND ALONE CONFIGURATION
B. COBAS C 111 WITH ISE STAND ALONE CONFIGURATION
Reason
This recall is related to a situation that due to a software limitation, a measurement timing error could occur under specific conditions while using the COBAS C111 (CAT #04528778001) OR THE COBAS C111 with ISE (ion-selective electrode) (CAT # 04777433001) Analyzers.
Affected products
A. COBAS C 111 STAND ALONE CONFIGURATION
Lot or serial number
Serial Number: 4234
Model or catalog number
04528778001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. COBAS C 111 WITH ISE STAND ALONE CONFIGURATION
Lot or serial number
Serial numbers:
S/N:50484
S/N:51459
S/N:51572
S/N:60142
S/N:60192
S/N:60289
S/N:60493
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY