Events

Recall of VITEK 2 GP ID

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
    41161
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-17
  • 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
    An internal investigation has confirmed occurrences of atypical negative o129r reactions for enterococcus casseliflavus atcc 700327t in association with three (3) vitek 2 gp id lots causing failure of the quality control (qc) testing for the vitek 2 gp id card.

Device

VITEK 2 GP ID
  • Model / Serial
    Model Catalog: 21342 (Lot serial: 2420348103)
  • Product Description
    VITEK 2 GP ID
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.