Events

Recall of ID DiaClon ABO / Rh, ID DiaClon ABO / Rh combi and ID DiaClon ABO / Rh D gel cards

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
    2004-06-14
  • 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-plusieurs-lots-de-cartes-gel-de-groupage-sanguin-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 Diamed company informed, on the 10/06/04, the users of the ID DiaClon ABO / Rh, ID DiaClon ABO / Rh combi and ID DiaClon ABO / Rh D gel cards, of the withdrawal of several batches. of these devices, a potential weakening of the reactions that can be observed at the end of its life. The users of this device concerned by this defect, in France, have received the enclosed mail (14/06/2004) ( 9 ko) .. The competent European authorities have been informed of this measure by the manufacturer. This information is intended for user EFS sites, laboratory managers, health facility directors and local vigilance correspondents for distribution to the relevant biology departments.

Device

ID DiaClon ABO / Rh, ID DiaClon ABO / Rh combi and ID DiaClon ABO / Rh D gel cards
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Diamed

Manufacturer

Diamed
  • Source
    LAANSM