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
    2005-10-27
  • 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-de-references-lots-du-dmdiv-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, the company DakoCytomation removed from the market the references and lots (27/10/2005) (155 Kb) cited in the appendix of the in vitro diagnostic medical device called EnVision +. This measure follows the discovery of an error in the formulation of the system of visualization kits of references and batches mentioned above, which may cause a slight decrease in the signal strength on some samples .. This device is used with mouse or rabbit 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 warned directly the recipients of the references / batches incriminated by means of the attached message (27/10/2005) (11 ko) validated by the Afssaps .. The European competent authorities concerned are informed directly by the manufacturer .. This information s address to laboratory managers, health facility directors and health-vigilance correspondents for dissemination, where appropriate appropriate to the services concerned.

Device

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

Manufacturer

DakoCytomation
  • Source
    LAANSM