Events

Retiro De Equipo (Recall) de Legiotop Ag

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 informed.

¿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
    2004-09-02
  • 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-de-deux-lots-de-legiotop-ag-societe-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
    In agreement with Afssaps, the company All Diag informed, on 01/09/04, the users of the reagent Legiotop Ag of several cases of false positives in the detection of the urinary antigen of Legionella pneumophilla, resulting in the withdrawal of both lots of Legiotop Ag currently marketed .. The users of this device concerned by this defect, in France, have received the attached mail (02/09/2004) (10 KB). The competent European authorities have not been informed of this measure because the device is marketed only in France. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for dissemination to the medical services. biology concerned.

Device

Legiotop Ag
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    All Diag informed

Manufacturer

All Diag informed
  • Source
    LAANSM