Events

Recall of VIDAS TOXO Competition

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by BIOMERIEUX.

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
  • Date
    2003-10-24
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-d-un-lot-du-dm-div-vidas-toxo-competition-de-par-biomerieux
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    The BIOMERIEUX company withdraws from the market the batch 775626401 (per.27.04.04) of the in vitro diagnostic medical device called VIDAS TOXO Competition - reference 30 211 following the possibility of obtaining false positive results. It should be noted that all positive result obtained with such a device must be completed by tests to identify at least two isotypes of immunoglobulin anti-toxoplasma (IgM and IgG). Thus, as a result, a false positive result can not ultimately be returned to a patient. This device allows the detection of total anti-Toxoplasma gondii immunoglobulins in human serum or plasma (lithium heparin or EDTA) by ELFA (Enzyme Linked Fluorescent Assay) technique on VIDAS automata.

Device

VIDAS TOXO Competition
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX