Events

Recall of Bicarbonate reagent

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 Randox.

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
    2007-06-26
  • 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-d-un-lot-du-reactif-bicarbonate
  • 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
    In agreement with the Afssaps, the company Randox proceeded, on 22/06/07, with the withdrawal of a lot of the reagent Bicarbonate. Users of these devices affected by this defect in France have received the following letter (22/06/2007) (18 KB) The competent European authorities have been informed of this measure by the manufacturer.

Device

Bicarbonate reagent
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Randox

Manufacturer

Randox