Events

Retiro De Equipo (Recall) de BETATOP UR5

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 ALL DIAG.

¿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
    2006-03-13
  • 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-tous-les-lots-du-dmdiv-betatop-ur5-all-diag
  • 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 March 10, 2006, the company ALL DIAG removed from the market all currently available batches of the in vitro diagnostic medical device called BETATOP UR5 reference 5401. This decision follows a discontinuation of marketing of this reagent motivated by several cases of false results. negative when screening for ß-hCG in serum. The company has directly notified the recipients of the offending lot by means of the attached message (13/03/2006) (19 KB) validated by Afssaps, supplemented by a letter Afssaps (13/03/2006) (33 KB) the procedures to be followed for patients who have been tested negative for ß-hCG with this reagent. 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

BETATOP UR5
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    ALL DIAG

Manufacturer

ALL DIAG
  • Empresa matriz del fabricante (2017)
    Biosynex
  • Source
    LAANSM