Events

Recall of Anti-Jka polyclonal

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 Biotest.

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
    2003-12-09
  • 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-du-dm-div-anti-jka-polyclonal-de-par-la-societe-biotest
  • 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
    Biotest withdraws from the market batches 1111201 (per.11.12.03), 1110902 (per.20.09.04) and 1110103 (per.17.01.05) of the in vitro diagnostic medical device called anti-Jka polyclonal - reference 808176, following a problem stability leading to a decline in the title over time and to obtain a lower than the required standards * .. This device of erythrocyte immunohematology, of human origin, is used for the research of the Jka erythrocyte antigen (antigen of the Kidd system). * The withdrawn lots are subject to the decree of February 8, 1984 relating to the characteristics and standards of the reagents used in erythrocyte immunology.

Device

Anti-Jka polyclonal
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Biotest

Manufacturer

Biotest
  • Source
    LAANSM