Events

Recall of Genscreen Ultra HIV Ag-Ab

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
    2010-02-26
  • 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-de-reactif-genscreen-ultra-hiv-ag-ab-commercialise-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
    In agreement with the Afssaps, the company Bio-Rad informed, on February 24, 2010, the users of the Genscreen Ultra HIV Ag-Ab reagent used for serological screening of HIV1 & 2, a batch withdrawal. health institutions concerned in France received the following letter (26/02/2010) (38 KB). The 7 EFS concerned by this defect, have received the attached mail (26/02/2010) (909 ko.) The competent European authorities have been informed of this measure by the manufacturer This information is intended for French Blood Establishments the directors of health establishments and local correspondents of reactive vigilance for dissemination to the biology departments concerned.

Device

Genscreen Ultra HIV Ag-Ab
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad