Cobas Infinity Central Lab (2020-01-07)
- Starting date:
- January 7, 2020
- Posting date:
- January 31, 2020
- 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-72215
Last updated: 2020-01-31
Affected Products
Cobas Infinity Central Lab
Reason
The manufacturer confirmed an issue with the cobas infinity using software version 3.00.00 To 3.01.04. When a QC alarm is received from the instrument and when working using the pass-through mode, the QC alarm is not sent to the external host
Affected products
Cobas Infinity Central Lab
Lot or serial number
- 81788
- 81966
Model or catalog number
07154003001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY