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
    54790
  • Event Risk Class
    II
  • Event Initiated Date
    2015-03-31
  • 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
    Out of range low (oorl) flucytosine (fct) qc results for candida krusei atcc 6258 the package insert qc strain has been identified in association with the vitec 2 ast-ys06 and ast-ys07 test kits.

Device

VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST CARDS
  • Model / Serial
    Model Catalog: 412 610 (Lot serial: More than 10 (contact Manuf.)); Model Catalog: 414 967 (Lot serial: More than 10 (contact Manuf.))
  • Product Description
    VITEK 2 COMPACT 30 SYSTEM - SUSCEPTIBILITY TEST C
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.