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
    111383
  • Event Risk Class
    II
  • Event Initiated Date
    2018-02-22
  • 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
    Internal investigation has demonstrated that in specific cases when a card is processed in and ejected from a slot number greater than 15 or 30 (all vitek 2 compact reader carousels contain 60 physical slots) respectively the final data packet for the card fails to be accepted by the computer and the isolate status remains at "preliminary". when the anomaly occurs subsequent data for current and future cards will not be transferred to the computer until the offending data packet is removed. since the card has completed processing as evidenced by the card ejection from the vitek 2 compact reader the results indicated in the lab report are the final results. as the card data for the ejected card will be lost after record removal it is recommended the user print the lab report prior to removal of the record.

Device

VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 27530 (Lot serial: All)
  • Product Description
    VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.