Events

Recall of IMx ESTRADIOL

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 ABBOTT FRANCE.

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
    1999-06-16
  • 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-reactif-denomme-imx-estradiol
  • 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 batches 49001M100, 51758M300 and 51585M300 of the reagent called "IMx ESTRADIOL" ref: 2215-22 of the ABBOTT FRANCE company are withdrawn from the market following a risk of lowered result for the samples whose estradiol level is higher than 1000 pg / ml.

Device

IMx ESTRADIOL
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    ABBOTT FRANCE

Manufacturer

ABBOTT FRANCE
  • Source
    LAANSM