Events

Recall of Enzygnost HIV Integral II reagent

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 Siemens.

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
    2012-12-21
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/reactif-enzygnost-hiv-integral-ii-siemens-retrait-de-lots
  • 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 Siemens company has informed the users of Enzygnost HIV Integral II reagent of the implementation of the withdrawal of two lots. The users concerned, in France, received the attached mail (21/12/2012) (56 KB). This information is addressed to the directors of health establishments, medical biologists and local correspondents of reactovigilance for diffusion to the concerned services.

Device

Enzygnost HIV Integral II reagent
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Siemens

Manufacturer

Siemens
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    LAANSM