Events

Recall of Reagents Vitros Immunodiagnostic Products / Prolactin Reagent Cartridge;Vitros immunodiagnostic Products / prolactin 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
    2000-08-11
  • 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-reactifs-denomme-vitros-immunodiagnostic-products-cartouche-de-reactifs-prolactine
  • 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
    Lot 90 (per 15.09.2000) of the reagent called Vitros Immunodiagnostic Products / prolactin reagent cartridge (reference 1849793) and batch 90 (per 15.09.2000) of the associated reagent called Vitros immunodiagnostic Products / prolactin standards (reference 1113596) of ORTHO-CLINICAL DIAGNOSTICS are withdrawn from the market due to the possibility of calibration failure.

Device

Reagents Vitros Immunodiagnostic Products / Prolactin Reagent Cartridge;Vitros immunodiagnostic P...

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS
  • Source
    LAANSM