Events

Retiro De Equipo (Recall) de TPHA ki

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 EUROBIO.

¿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
    2003-02-07
  • 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-dispositif-medical-de-diagnostic-in-vitro-denomme-kit-tpha-ref--shasyp00-8t-par-les-laboratoires-eurobio
  • 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
    The EUROBIO laboratories are removing from the market Lot 21903R (January 2004 issue) of the in vitro diagnostic medical device called: TPHA kit - reference SHASYP00-8T, due to a problem of stability of one of the components of the kit leading to a decrease results obtained for the positive control (titre of 640 instead of 2560) and for the patient samples and possibly, as part of the qualitative method in the serodiagnosis of syphilis, to a possibility of false negative results. as a precautionary measure, in agreement with AFSSAPS, biologists are asked to reconsider all syphilis serodiagnostics concerned by this batch (present on the French market since November 18, 2002) and rendered negative. A note. : in the case of a negative test, the instructions for use of the kit advise to complete the profile of the results by practicing a RPR / VDRL-Coal on the sample. This device allows the detection and the titration of the anti-antibodies. Treponema pallidum in the serodiagnosis of syphilis.

Device

TPHA ki
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    EUROBIO

Manufacturer

EUROBIO
  • Source
    LAANSM