Health product recall

Cobas Infinity Central Lab (2021-01-21)

Starting date:
January 21, 2021
Posting date:
February 5, 2021
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-74909

Last updated:
2021-02-05

Affected Products 

Cobas Infinity Central Lab

Reason

The manufacturer confirmed an issue with the cobas infinity using software version 3.00.00 And onwards. Under certain circumstances, the SI_WSI result status is removed from the SI sensitive test when alphanumeric results are received

Affected products

Cobas Infinity Central Lab

Lot or serial number

Software versions 3.00.00 and above. 

Model or catalog number

7154003001

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY