Events

Recall of VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT

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
    25588
  • Event Risk Class
    II
  • Event Initiated Date
    2015-01-07
  • 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
    A discrepant inoculum density range has been identified for the neisseria haemophilus (nh) identification (id) test card in the vitek 2 7.01 product information document (ref 514740-1xx1 where xx indicates the language translation code).

Device

VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 27530 (Lot serial: Not applicable); Model Catalog: 27225 (Lot serial: Not Applicable); Model Catalog: 27560 (Lot serial: Not Applicable)
  • Product Description
    VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.