Health product recall

Cobas 6500 - Cobas U Cuvette (2017-09-14)

Starting date:
September 14, 2017
Posting date:
February 22, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66022

Affected products

Cobas 6500 - Cobas U Cuvette

Reason

There is a potential contamination of the cuvettes of the Cobas U Cuvette which may lead to false positive result for the parameter bacteria (bac) on the Cobas U701 microscopy analyzer. Only lot 16483701 is affected by this issue.

Affected products

Cobas 6500 - Cobas U Cuvette

Lot or serial number

16483701

Model or catalog number

06390552001

Companies
Manufacturer
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY