Events

Recall of DiaClon anti-Jkb

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 Diamed.

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
    2004-03-16
  • 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-d-un-lot-du-reactif-diaclon-anti-jkb-de-la-societe-diamed
  • 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 DiaMed informed the 12/03/04, the users of the reagent DiaClon anti-Jkb the withdrawal of a lot .. The 5 health facilities, as well as the 15 EFS concerned by this withdrawal , in France, have received the following letter (12/03/2004) (17 KB). The competent European authorities have been informed of this measure by the manufacturer DiaMed AG .. This information is intended for managers of health facilities, the directors of the EFS and local correspondents of reactive vigilance for diffusion to the laboratories concerned.

Device

DiaClon anti-Jkb
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Diamed

Manufacturer

Diamed
  • Source
    LAANSM