Events

Recall of Genscreen Plus 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
    2005-06-28
  • 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-de-lots-du-dmdiv-genscreen-plus-hiv-ag-ab-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
    On June 24, 2005, Bio-Rad removed the lot from the market. 4M0051 (per 30/05/2006). 4L0576 (per 15/04/2006). 4L1576 (per 15/04/2006). 4L0577 (per 30/04/2006). 5A0578 (30/05/2006). 5B0579 (per 15/06/2006) of the in vitro diagnostic medical device known as Genscreen Plus HIV Ag-Ab references 72375 and 72376 .. This decision follows the possible instability of the conjugate R6 (polyclonal antibodies of sheep biotinylated anti-p24 HIV1) of the kit, resulting in positive HIV Ag control values ​​below the cut-off, thereby invalidating the assay series Previously, this possibility of instability led to the removal of lot 4L0575 on February 25, 200. .. This device is a kit for the detection of HIV infections in human serum / plasma by enzyme immunoassay technique. The company has directly notified the recipients of the incriminated batches by means of the attached message (24/06/2005 ) (17 ko) validated by Afssaps. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to patients. concerned.

Device

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

Manufacturer

Bio-Rad