Events

Recall of bioMerieux VIDAS TOXO IgM

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    19787
  • Event Initiated Date
    2016-02-26
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • Reason
    Following a complaint from a customer related to discrepant results observed when testing heat inactivated sera, biomérieux performed an investigation concluding that the performance of vidas toxo igm kit using heat inactivated sera (56°c for 30 minutes) is not in accordance with the performance characteristics as stated in the ifu. the investigation confirmed that the index results obtained with inactivated sera are lower compared to values obtained with fresh sera and may result in false negative results.
  • Action
    Product to be returned to supplier

Device

bioMerieux VIDAS TOXO IgM
  • Model / Serial
    Model: 30202, Affected: multiple lot numbers
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA