Events

Recall of VIRONOSTIKA HIV-1 Ag

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
    2003-01-09
  • 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-dm-div-vironostika-hiv-1-ag-ref-284033-de-la-societe-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 Biomérieux company withdraws from the market lots V93HA and V93HB (expiry 28.08.03) of the in vitro diagnostic medical device called VIRONOSTIKA HIV-1 Ag / reference 284033, following a decrease in sensitivity that may induce a decrease in P24 antigen titres in particular. in the case of very early seroconversion sera. This device is used for the determination of HIV antigenemia (P24 antigen)

Device

VIRONOSTIKA HIV-1 Ag
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX