Cobas 6500 U601 Urinalys system-Urine Analyzer and Cobas U701 Microscopy Analyzer (2018-07-19)
- Starting date:
- July 19, 2018
- Posting date:
- August 17, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67440
Affected products
- Cobas 6500 U601 Urinalys system-Urine Analyzer
- Cobas U701 Microscopy Analyzer
Reason
The manufacturer confirmed that when working in barcode mode during processing of sample measurements on Cobas u601 and Cobas u701 analyzers, a possible sample mismatch may occur in very rare circumstances when the instructions are not followed.
Affected products
A. Cobas 6500 U601 Urinalys system-Urine Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
06390498001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. Cobas U701 Microscopy Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
06390501001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY