Events

Retiro De Equipo (Recall) de Flavicheck HCV

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Qualpro / Servibio.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • Fecha
    2008-09-05
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retraits-de-produits-reactif-flavicheck-hcv-qualpro-servibio
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Acción
    Recall of all lots of Flavicheck HCV reagent marketed by Qualpro and distributed by Servibi. In agreement with Afssaps, following the discontinuation of the distribution of 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 performance defect. Recommendations issued by Afssaps concerning the retest of negative samples are attached to mail sent to users. The users of this device concerned by this defect in France have received the enclosed mail. 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. Distribution stop. Recommendation Afssaps (04/09/2008) (23 KB Joint mail (04/09/2008) (27 KB)

Device

Flavicheck HCV
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    Qualpro / Servibio

Manufacturer

Qualpro / Servibio