Cobas Infinity Central Lab (2019-09-26)
- Starting date:
- September 26, 2019
- Posting date:
- October 25, 2019
- 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-71377
Last updated: 2019-10-25
Affected Products
Cobas Infinity Central Lab
Reason
When cobas infinity receives results from an instrument with an alarm code that is not mapped in infinity, if there is a mapped alarm whose first characters (as many characters as the incoming alarm code has) match the received alarm code, cobas infinity incorrectly assigns this mapping to the received alarm.
Affected products
Cobas Infinity Central Lab
Lot or serial number
Software vers.:3.00.00-3.01.02
Model or catalog number
7154003001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY