Events

Retiro De Equipo (Recall) de SYNCHRON® Systems Reactive Wash Concentrate II

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
    2005-08-11
  • 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-synchron-systems-reactif-wash-concentrate-ii-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
    On August 10, 2005, Beckman Coulter withdrew the batch T502014 (expiry 28/02/2007) of the in vitro diagnostic medical device called SYNCHRON® Systems Reactive Wash Concentrate II - reference 450160. This device is a detergent dedicated to Synchron CX controllers.This recall is made because some cans may leak when placed in the PLC and subjected to the pressure of 5 PSI. The company Beckman Coulter has directly notified the recipients of the offending lot by means of the attached message (10/08/2005) (23 KB) validated by Afssaps. The European Competent Authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

SYNCHRON® Systems Reactive Wash Concentrate II
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER

Manufacturer

BECKMAN COULTER