Events

Retiro De Equipo (Recall) de ACCESS® AFP

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 BECKMAN COULTER.

¿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
    2004-10-07
  • 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-access-afp-de-par-beckman-coulter
  • 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
    The company Beckman Coulter withdraws from the market batches 415515 (per.30.09.05), 416251 and 416781 (per 31.10.05) of the in vitro diagnostic medical device called ACCESS® AFP - reference 33210, following the formation of a precipitates blocking agents present in the reagent, which may result in undervalued quality control results, outside the acceptance ranges. It was found that this only affected the results of samples with an alpha-fetoprotein (AFP) concentration of less than 18 ng / ml. The Beckman Coulter company has directly informed the recipients of these batches. This information is intended for directors and correspondents of reactive vigilance for dissemination, where appropriate, to the services concerned.

Device

ACCESS® AFP
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER