Events

Recall of VITEK 2 COMPACT 60 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
    15350
  • Event Risk Class
    III
  • Event Initiated Date
    2015-02-17
  • 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
    Vitek 2 7.01 software introduced a feature (enable - convention for highest reportable mic) that can be used to modify the reporting convention when an ast result is within the highest reportable mic range. advanced expert system (aes) parameter sets are configurable in the vitek 2 software to allow users to select mic breakpoint interpretation as well as aes functionality related to recommended guidelines. when "enabled - convention for highest reportable mic configuration option modifies the highest reportable mic value for each specific antimicrobial to half its doubling dilution and displays the value with a "greater than" symbol.

Device

VITEK 2 COMPACT 60 SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 27560 (Lot serial: Version 7.01); Model Catalog: 27530 (Lot serial: Version 7.01); Model Catalog: 27225 (Lot serial: Version 7.01)
  • Product Description
    Software for VITEK 2 COMPACT 60 SYSTEM
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.