Events

Retiro De Equipo (Recall) de IMMULITE 2000 Testosterone Total

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 DPC 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
    2006-01-10
  • 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-et-information-sur-un-lot-du-dmdiv-immulite-2000-testosterone-totale-dpc-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 January 6, 2006, DPC France withdrew from the market part of lot 126 of the in vitro diagnostic medical device called IMMULITE 2000 Testosterone Total reference L2KTW. This device is used for the quantitative determination of total testosterone in serum with the IMMULITE 2000 analyzer. This decision is motivated by the fact that this lot contains a raw material that could interfere with the IMMULITE 2000 Estradiol assay (ref. L2KE2) thus causing an overestimation of the concentrations observed in Estradiol. Since the performance of lot 126 is not affected by this raw material, this recall only concerns recipients of the lot who use the IMMULITE 2000 assay on the same machine. estradiol. The company has directly notified all recipients of the offending lot by means of the message attached (06/01/2006) (134 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

IMMULITE 2000 Testosterone Total
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    DPC France

Manufacturer

DPC France
  • Source
    LAANSM