Health product recall

Cobas p 612 pre-analytical system LCP1 (2018-07-12)

Starting date:
July 12, 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-67304

Affected products

Cobas p 612 pre-analytical system LCP1

Reason

Sample material may potentially come in contact with the pipetting nozzle during operation when physically configured to use non-filter tips causing contamination which may result in potential false positive results depending on the sensitivity of the analytical technology.

Affected products

Cobas p 612 pre-analytical system LCP1

Lot or serial number

Software version 2.0 and higher

Model or catalog number

07563116001

Companies
Manufacturer
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY