Events

Recall of HDL Cholesterol / Phospholipids

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 BIOMÉRIEUX SA.

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
    2000-07-13
  • 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-reactif-denomme-hdl-cholesterol-phospholipides
  • 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
    Batches 730643001 (expiry date 11.06.2001), 735480101 (expiry date 17.08.2001), 737735301 (expiry date 03.11.2001), 739475801 (expiry date 30.12.2001) of the reagent called HDL Cholesterol / Phospholipids - reference 61531 from the company BIOMÉRIEUX SA are withdrawn of the market following a decrease in the HDL cholesterol level of the calibrator present in the kit.

Device

HDL Cholesterol / Phospholipids
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BIOMÉRIEUX SA

Manufacturer

BIOMÉRIEUX SA
  • Source
    LAANSM