Health product recall

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