Events

Recall of VIDAS TOXO IgM Assay (used for the detection of toxoplasmosis antibodies). An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Biomerieux Australia Pty Ltd.

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
    RC-2016-RN-00159-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00159-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • 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 while using with 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. in remote cases this may result in a delayed diagnosis and treatment for immunocompromised patients, organ transplanted patients, foetuses (in the case of gestational infection) and neonates.
  • Action
    Biomerieux is advising users to not use heat inactivate sera before testing. Any concerns regarding previously generated results should be discussed with the Laboratory Director.

Device

VIDAS TOXO IgM Assay (used for the detection of toxoplasmosis antibodies). An in vitro diagnostic...
  • Model / Serial
    VIDAS TOXO IgM Assay (used for the detection of toxoplasmosis antibodies). An in vitro diagnostic medical device (IVD)Reference Number: 30202Multiple Lot Numbers affectedARTG Number: 209618
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd