Events

Retiro De Equipo (Recall) de RAPIDSIGNAL Troponine I

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 Inverness Medical France.

¿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
    2005-03-14
  • 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-rapidsignal-troponine-i-par-inverness-medical-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 March 11, 2005, Inverness Medical France withdrew from the market lots 041201A and 041024A of the in vitro diagnostic medical device called RAPIDSIGNAL Troponine I reference 71528010 (manufacturer Orgenics Ltd) following a report of false negative result. The marketing of this reference is suspended from lot 041201A pending the results of the manufacturer's investigation. The company has directly notified the recipients of the offending lots by means of the attached message (11/03/2005) (21 KB) validated by Afssaps. The relevant European Competent Authorities are informed directly by the manufacturer. is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

RAPIDSIGNAL Troponine I

Manufacturer

Inverness Medical France
  • Source
    LAANSM