Events

Recall of Genscreen Plus 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
    2005-03-01
  • 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-genscreen-plus-hiv-ag-ab
  • 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
    On February 25, 2005, BIO-RAD withdrew from the market lot 4L0575 of the in vitro diagnostic medical device called Genscreen Plus Ag-Ab reference 72376 following a possible decrease in the Optical Density value of the HIV positive control resulting in a invalidation of the results .. The company BIO-RAD has directly notified the recipients of the offending lot by means of the attached message (25/02/2005) (15 ko). This information is intended for laboratory managers, managers health establishments and to the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

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

Manufacturer

Bio-Rad