Events

Recall of VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST CARDS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOMERIEUX CANADA INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    34992
  • Event Risk Class
    III
  • Event Initiated Date
    2013-12-24
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    There have been recent complaints that the vitek 2 meropenem (mem mem02n) 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.

Device

VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST CARDS
  • Model / Serial
    Model Catalog: 413085 (Lot serial: ALL LOT NUMBERS); Model Catalog: 413082 (Lot serial: ALL LOT NUMBERS); Model Catalog: 413066 (Lot serial: ALL LOT NUMBERS); Model Catalog: 413063 (Lot serial: ALL LOT NUMBERS); Model Catalog: 413062 (Lot serial: ALL LOT NUMBERS); Model Catalog: 411021 (Lot serial: ALL LOT NUMBERS); Model Catalog: 410102 (Lot serial: ALL LOT NUMBERS); Model Catalog: 416710 (Lot serial: ALL LOT NUMBERS); Model Catalog: 414125 (Lot serial: ALL LOT NUMBERS); Model Catalog: 410101 (Lot serial: ALL LOT NUMBERS); Model Catalog: 413710 (Lot serial: ALL LOT NUMBERS); Model Catalog: 413143 (Lot serial: ALL LOT NUMBERS); Model Catalog: 413083 (Lot serial: ALL LOT NUMBERS)
  • Product Description
    VITEK 2 SYSTEM - SUSCEPTIBILITY TEST CARDS
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.