Events

Retiro De Equipo (Recall) de EnVision +

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 DakoCytomation.

¿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
    2006-05-02
  • 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/retrait-d-un-lot-du-dmdiv-kit-envision-dakocytomation
  • 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
    In agreement with Afssaps, DakoCytomation has withdrawn lot 085032r from the in vitro diagnostic medical device called Kit EnVision +, reference K4001. This measure follows the identification of an error in the formulation of the visualization system that may lead to a decrease in signal intensity on some samples. This device is used with mouse primary antibodies provided by the user, for the qualitative identification of antigens by light microscopy in paraffin-embedded normal and pathological tissues, sections of tissue cryostats or cell preparations. The company has directly notified the recipients of the offending lot by means of the enclosed message (02/05/2006) (14 ko) validated by Afssaps. The European competent authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

EnVision +
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    DakoCytomation

Manufacturer

DakoCytomation
  • Source
    LAANSM