Events

Retiro De Equipo (Recall) de VITROS® AFP;VITROS® CA 19-9

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 Ortho-Clinical 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
    2004-11-04
  • 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-vitros-ca-19-9-de-par-ortho-clinical-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 3, 2004, Ortho-Clinical Diagnostics removed lot 660 (per 28.01.05) from the in vitro diagnostic medical device called VITROS® AFP - reference 192 5551 and lot 670 (per 07.12.04). ) of the in vitro diagnostic medical device known as VITROS® CA 19-9 - reference 680 0040, following the finding of results inferior to those expected; this anomaly is due to the production of a light signal lower than that expected by some wells. The company Ortho-Clinical Diagnostics has directly informed the recipients of the incriminated lots by means of the message attached (03/11/2004) ( 22 kb). The competent authorities have been notified directly by the manufacturer. This information is addressed to the directors of health establishments and correspondents of réactovigilance for diffusion, if necessary, with the services concerned.

Device

VITROS® AFP;VITROS® CA 19-9

Manufacturer

Ortho-Clinical Diagnostics