Events

Recall of Flavicheck HCV 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 Qualpro.

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
    2008-09-04
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-tous-les-lots-de-reactif-flavicheck-hcv-commercialise-par-qualpro-et-distribue-par-servibio
  • 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 Afssaps, following the cessation of distributio. of the Flavicheck HCV reagent carried out on 19/08/08, the company Qualpro, proceeded, on 01/09/08, to the withdrawal of all lots available on the market due to a lack of performance. Recommendations issued (04/09/2008) (23 KB) by the Afssaps concerning the retest of negative samples are attached to the mail sent to users. The users of this device concerned by this defect in France have received the following letter (04/09/2008) (27 KB). The competent European authorities have been informed of this measure by Afssaps. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.

Device

Flavicheck HCV reagent
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Qualpro

Manufacturer

Qualpro