Events

Retiro De Equipo (Recall) de STA® Liatest® D-Di

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 Diagnostica Stago.

¿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
    2005-10-10
  • 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-d-un-lot-du-dmdiv-sta-r-liatest-r-d-di-diagnostica-stago
  • 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 October 06, 2005, Diagnostica Stago withdrew from the market lot 050625 of the in vitro diagnostic medical device called STA® Liatest® D-Di reference 00515 following the demonstration of an unusually low reactivity for this lot. However, this batch still conforms to the expected analytical performance. This is a precautionary measure considering the potential loss of reactivity over time. This device is used for the quantitative determination of D-Dimer on STA® line devices by immuno-turbidimetric method. The company has directly notified the recipients of the offending batch by means of the attached message (06/10/2005) (57 KB) validated by the Afssaps. This information is intended for laboratory managers, directors of establishments of health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.

Device

STA® Liatest® D-Di
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    Diagnostica Stago

Manufacturer

Diagnostica Stago