Events

Recall of Enzygnost HIV Integral II

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 DADE BEHRING.

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
    2004-08-02
  • 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-du-reactif-enzygnost-hiv-integral-ii-de-la-societe-dade-behring
  • 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 Afssaps, the company Dade Behring informed, on 29/07/04, the users of the laboratory reagent Enzygnost HIV Integral II the withdrawal of this device because of a risk of false negative results, appeared recently, following reports of two cases of abnormally weak signals, reported with positive samples. The users of the device concerned by this defect, in France, have received the attached mail (02/08/2004) (14 KB). This measure has been notified to the competent European authorities by Germany. address to laboratory managers, health facility directors and local vigilance correspondents for distribution to relevant biology departments.

Device

Enzygnost HIV Integral II
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DADE BEHRING

Manufacturer

DADE BEHRING
  • Source
    LAANSM