Events

Retiro De Equipo (Recall) de BD Vacutainer® Glass Tube with Citrate

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 BECTON DICKINSON.

¿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
    2005-06-02
  • 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-tube-bd-vacutainer-r-en-verre-avec-citrate-becton-dickinson-france
  • 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 May 30, 2005, Becton Dickinson France SA withdrew from the market lot 5005913 (per 06/2006) of the in vitro diagnostic medical device known as BD Vacutainer® Glass Tube with Citrate (reference 367704) following the implementation of evidence of an excessive amount of citrate in some tubes in this lot altering the blood / anticoagulant ratio, resulting in longer coagulation times and a lower concentration of coagulation markers. The company directly notified the recipients of the batch incriminated by means of the attached message (30/05/2005) (89 ko) validated by the Afssaps .. The competent European 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

BD Vacutainer® Glass Tube with Citrate
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    BECTON DICKINSON

Manufacturer

BECTON DICKINSON