Events

Recall of ETI / ANA / ENA 8 Profile 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 DiaSorin.

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
    2013-08-19
  • 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-eti-ana-ena-8-profile-diasorin-retrait-d-un-lot2
  • 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 company DIASORIN sent to the users of the ETI / ANA / ENA 8 Profile rectifier rectification of the batch number concerned by the recall implemented in June 2013. The users concerned, in France, received the email attached (19/08 / 2013) (56 KB). This information is addressed to the directors of health establishments and local correspondents of reactive vigilance for broadcasting to the services concerned. Read too. ETI / ANA / ENA 8 Profile reagent - DIASORIN - Batch removal

Device

ETI / ANA / ENA 8 Profile reagent
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DiaSorin

Manufacturer

DiaSorin