Health product recall

COBAS INFINITY CENTRAL LAB (2019-05-30)

Starting date:
May 30, 2019
Posting date:
November 27, 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-74405

Last updated:
2020-11-27

Affected Products

COBAS INFINITY CENTRAL LAB

Reason

The manufacturer Roche Diagnostics GmbH recall the Cobas infinity (cat # 07154003001 SW V3.00.00 Onwards) for a potential incorrect results validation due to an erroneous QC status when using "Status Expiration Control" rule.

Affected products

COBAS INFINITY CENTRAL LAB

Lot or serial number

7154003001

Model or catalog number

7154003001

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY