Events

Retiro De Equipo (Recall) de Elecsys 2010 assay tips

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 Roche Diagnostics.

¿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
    2005-11-15
  • 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-elecsys-2010-assay-tips-roche-diagnostics
  • 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 November 10, 2005, the company ROCHE Diagnostics removed from the market the batch 05053110 of the in vitro diagnostic medical device called Elecsys 2010 assay tips reference 11706799 following the possibility that some tips of this lot can be plugged because of a mold of This fault leads either to an error message 58 S without result, or to values ​​that are too high or too low, all of which are respectively accompanied by alarms 51 or 50 on the Elecsys analyzer 2010. The company has directly notified the recipients of the offending lot by means of the attached message (10/11/2005) (50 KB) validated by Afssaps. The European competent authorities concerned are informed directly by the manufacturer. address to the laboratory managers, the directors of the health establishments and the reactovigilance correspondents for diffusion, if necessary, to the services concerned.

Device

Elecsys 2010 assay tips
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics