Cobas 6500 Cobas u 601 and u 701 (2018-06-20)
- Starting date:
- June 20, 2018
- Posting date:
- July 27, 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-67300
Affected products
A. Cobas 6500 Cobas u 601
B. Cobas 6500 Cobas u 701
Reason
A software limitation may occur on the cobas 6500 urine analyzer which may lead to samples not being measured on cobas u701 instrument when the test profile ''u601 sieve to u701'' is used. This software limitation is included in the software versions 2.2.3, 2.2.4 and 2.2.5 only.
Affected products
A. Cobas 6500 Cobas u 601
Lot or serial number
software version 2.2.3
software version 2.2.4
software version 2.2.5
Model or catalog number
06390498001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. Cobas 6500 Cobas u 701
Lot or serial number
software version 2.2.3
software version 2.2.4
software version 2.2.5
Model or catalog number
06390501001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY