Events

Recall of SECURICARD 3;SECURICARD 1

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 Institut Jacques Boy.

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
    2003-02-17
  • 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-dispositifs-medicaux-de-diagnostic-in-vitro-securicard-par-la-societe-institut-jacques-boy
  • 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
    Institut Jacques Boy withdraws lot 264802 (per.31.07.03) from the market for the in vitro diagnostic medical device called SECURICARD 3 - reference 109010124 and lots 082802 (per.31.05.03); 284402 (per.31.07.03); 024902 (per.31.07.03) of the in vitro diagnostic medical device called SECURICARD 1 - reference 109010224, following a possible weakening of the anti-B antibody of these pre-transfusion control devices causing a difficulty of reading and a possibility of misinterpretation of tests.

Device

SECURICARD 3;SECURICARD 1

Manufacturer

Institut Jacques Boy
  • Source
    LAANSM