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