Vitek 2, Vitek 2 Compact 30, and Vitek 2 Compact 60 system susceptibility test cards (2013-12-23)

Starting date:

December 23, 2013

Posting date:

February 11, 2014

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-37889

• 
  Reason
• 
  Affected products

Recalled Products

1. Vitek 2 Compact 30 System - Susceptibility Test Cards
2. Vitek 2 Compact 60 System - Susceptibility Test Cards
3. Vitek 2 System - Susceptibility Test Cards

Reason

There have been recent complaints that the Vitek 2 Meropenem (Mem, Mm02N) is overcalling resistance for isolates of Aeromonas hydrophila. False resistance was confirmed when isolates from customer sites were tested internally by broth microdilution (BDM) the reference method used for development of MEM02N.

Affected products