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

• 
  Reason
• 
  Affected products

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