Recall of Diaclon anti-Jkb monoclonal (clone MS8)

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
    2004-02-02
  • Event Country
  • Event Source
    ANSM
  • Event Source URL
  • 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, on 24 January 2004, Diamed informed the users concerned of the withdrawal from the French market of lot 502 80 3402 (per.31.05.04) of the in vitro diagnostic medical device called ID-Cards Diaclon anti-Jkb monoclonal (clone MS8) - reference 007331, following the reporting of a false negative Jkb phenotype and waiting for additional information. This erythrocyte immunohematology device is used for the detection of the erythrocyte antigen Jkb (antigen of the Kidd system).

Device

  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer

Manufacturer

  • Source
    LAANSM