Health product recall

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