Events

Recall of VIDAS SYSTEM - TOXO IGM (TXM) ASSAY

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
    44505
  • Event Risk Class
    II
  • Event Initiated Date
    2016-02-08
  • 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
    An external study showed that performing tests with inactivated sera provides discrepend results. the index results obtained testing inactivated serum are lower compared to values obtained with fresh serum. this could lead for borderline sample to a drift in the overall result interpretation (i.E. from positive to equivocal from equivocal to negative from positive to negative).

Device

VIDAS SYSTEM - TOXO IGM (TXM) ASSAY
  • Model / Serial
    Model Catalog: 30202 (Lot serial: More than 10-contact manuf.)
  • Product Description
    VIDAS SYSTEM - TOXO IGM (TXM) ASSAY
  • Manufacturer
    BIOMERIEUX CANADA INC.

Manufacturer

BIOMERIEUX CANADA INC.