Events

Recall of Vitros Immunodiagnostic Products / Estradiol reagent cartridge;Vitros Immunodiagnostic Products / Estadiol Standards

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 ORTHO CLINICAL DIAGNOSTICS.

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
    2000-05-23
  • 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-reactifs-denomme-vitros-immunodiagnostic-products
  • 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 batch 134 of the reagent called Vitros Immunodiagnostic Products / Estradiol reagent cartridge (reference 8552630), and, consequently, the batch 134 of the reagent called Vitros Immunodiagnostic Products / Estadiol Standards (reference 1318930), obligatorily used with the first, of ORTHO CLINICAL DIAGNOSTICS are withdrawn from the market due to a risk of overestimation (3 SD ie 15-35%) of estradiol concentrations in patient samples and controls.

Device

Vitros Immunodiagnostic Products / Estradiol reagent cartridge;Vitros Immunodiagnostic Products /...

Manufacturer

ORTHO CLINICAL DIAGNOSTICS