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
    28731
  • Event Risk Class
    III
  • Event Initiated Date
    2011-08-03
  • 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
    The vitek 2 systems bioart rules that enforce the limitations of cronobacter sakazakii (c. sakazakii) are not included in the pre-defined bioart limitation rules released in the version 5.01 software. enterobacter sakazakii was moved out of the enterobacter species group and renamed to c. sakazakii group. these pre-defined bioart rules were not updated to include c. sakazakii group therefore the rules are not appropriately applied when the organism identification is c. sakazakii group.

Device

VITEK 2 COMPACT 30 SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 27530 (Lot serial: ); Model Catalog: 27560 (Lot serial: ); Model Catalog: 27225 (Lot serial: ); Model Catalog: 27227 (Lot serial: )
  • Product Description
    VITEK 2 Compact 30 System
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.