Events

Recall of VITEK MS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOMERIEUX SA.

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
    23068
  • Event Risk Class
    II
  • Event Initiated Date
    2013-10-07
  • 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
    Some issues have been reported when firmware version 3.13 was installed on systems equipped with the old transient recorder (tr) board (ref. 6200350). extenisve testing has proven that firmware 3.13 may potentially cause an instrument to freeze or hang during acquisition when installed with the old tr board with a risk repeated results for different spots.

Device

VITEK MS
  • Model / Serial
    Model Catalog: 410710 (Lot serial: S/N BELOW 50039 AND ABOVE); Model Catalog: 410895 (Lot serial: 60000 ARE CONCERNED); Model Catalog: 410710 (Lot serial: 60000 ARE CONCERNED); Model Catalog: 410895 (Lot serial: EXCEPTION 50050 IS ALSO); Model Catalog: 410710 (Lot serial: EXCEPTION 50050 IS ALSO); Model Catalog: 410895 (Lot serial: CONCERNED.); Model Catalog: 410710 (Lot serial: CONCERNED.); Model Catalog: 410895 (Lot serial: S/N BELOW 50039 AND ABOVE)
  • Product Description
    VITEK MS
  • Manufacturer
    BIOMERIEUX SA

Manufacturer

BIOMERIEUX SA