Health product recall

COBAS INFINITY CENTRAL LAB (2021-06-30)

Starting date:
June 30, 2021
Posting date:
July 16, 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-76023

Last updated: 2021-07-15

Affected Products

COBAS INFINITY CENTRAL LAB

Reason

Under certain circumstances, the result of cobas e flow tests could be replaced by an automatic result. This automatic result could be released and interpreted as a positive/negative result.

Affected products

COBAS INFINITY CENTRAL LAB

Lot or serial number

SW versions 3.01.03 to 3.03.03

Model or catalog number

7154003001
9180443001

Companies
Manufacturer
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY