Events

Recall of Pastorex Toxo

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 Bio-Rad.

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
    2003-08-28
  • 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-dmdiv-pastorex-toxo-ref--72724-de-par-la-societe-bio-rad
  • 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 company BIO-RAD withdraws from the market lot 3G0158 (per 15.06.04) of the in vitro diagnostic medical device called Pastorex Toxo - reference 72724, following the observation of a significant increase in non-specific results, due to a increased sensitivity of the latex used for this batch. This device makes it possible to detect anti-Toxoplasma gondii antibodies in the serum by an agglutination test of latex particles. This defect does not entail any risk of erroneous patient results since the negative control is also concerned and since any positive result must be confirmed - as mentioned in the leaflet - by another technique allowing to specify the class and the title of the antibodies.

Device

Pastorex Toxo
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad