Events

Recall of DiaClon Anti-Lea ID-Card

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
    2005-11-15
  • 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-lots-de-carte-id-diaclon-anti-lea-et-de-carte-id-antigen-profile-i-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
    The DIAMED company has informed the Afssaps of the recall of lots 50241.30.01 (per 30/11/05), 50241.30.02 (per 31/12/05), 50241.30.03 (per 31/01/06) of the DMDIV called DiaClon Anti-Lea ID-Card, reference 007221 and lot 50371.02.01 (per 30/11/05) of the DMDIV called Antigen ID-card profile I, reference 008510 .. These devices are used for the determination of the Lewis antigen has (inter alia, for the Antigen I-profile card I) thanks to monoclonal anti-Lea antibodies included in the gel. This measure follows the demonstration of a weakening of the reactivity of the monoclonal antibodies. anti-Lea .. This information is intended for laboratory managers, directors of health establishments and correspondents for reactive vigilance for dissemination, where appropriate, to the services concerned.

Device

DiaClon Anti-Lea ID-Card
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Diamed

Manufacturer

Diamed
  • Source
    LAANSM