Health product recall

Cobas Infinity Central Lab (2019-12-19)

Starting date:
December 19, 2019
Posting date:
January 31, 2020
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-72207



Last updated: 2020-01-31

Affected Products

Cobas Infinity Central Lab

Reason

The manufacturer has identified that subsequent to an alarm starting with a " < " symbol, the alarm flag IDs are not displayed in the validation screen of the system. Note (from the manufacturer): there is no impact for the systems in the canadian market.

Affected products

Cobas Infinity Central Lab

Lot or serial number
  • 81788
  • 81966
  • v2.xx
  • v3.xx
Model or catalog number

7154003001

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY