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cobas Urinalysis System and Microscopy Analyzer (2016-07-04)
- Starting date:
- July 4, 2016
- Posting date:
- July 22, 2016
- 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-59478
Affected products
- COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZE
- COBAS 6500 - COBAS U701 MICROSCOPY ANALYZER
Reason
During internal investigation, our manufacturer confirmed a possible software issue where the strips cassettes (cobas u pack) on cobas u 601 urinalysis system is denied by the user software although the expiry date has not been reached. This is true for every month reaching the cassette expiry date.
Affected products
A. COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZE
Lot or serial number
Software v. less or eq 2.2.1.
Model or catalog number
6390498001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. COBAS 6500 - COBAS U701 MICROSCOPY ANALYZER
Lot or serial number
Software v. less or eq 2.2.1.
Model or catalog number
6390501001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY