Events

Retiro De Equipo (Recall) de HercepTest Autostainer

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
    2005-10-13
  • 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-lots-du-dmdiv-herceptest-autostainer-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
    On October 11, 2005, DakoCytomation withdrew from the market batches 00016965 and 00018107 of the in vitro diagnostic medical device called HercepTest Autostainer reference K5207 following the posibility of obtaining falsely reduced marking intensity. This device is used to the semi-quantitative immunocytochemical assay that determines the overexpression of the HER2 protein in breast cancer tissues. This dosage is indicated in the evaluation of the patients for whom treatment with Herceptin® is envisaged. The company directly informed the recipients of the incriminated batches by means of the attached message (13/10/2005) (18 KB) validated by AFSSAPS .. The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for laboratory managers, directors of health establishments and health-vigilance correspondents for the dissemination, where appropriate, of services. concerned.

Device

HercepTest Autostainer
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    DakoCytomation

Manufacturer

DakoCytomation
  • Source
    LAANSM