Events

Retiro De Equipo (Recall) de DRUGCHECK

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 ALL DIAG.

¿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
    2005-07-04
  • 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-drugcheck-10-all-diag
  • 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 June 30, 2005, the company ALL DIAG withdrew from the market the batch DOA5030060 of the in vitro diagnostic medical device called DRUGCHECK reference 5456. This decision follows the detection of non-compliant labeling on the cassettes. Indeed, the sequence of the various narcotics recorded on the tape is wrong, resulting in a possibility of rendering a false positive result for a given narcotic and falsely negative for a second .. This device is a rapid test of simultaneous detection of a panel of The company has directly notified the recipients of the offending batch by means of the attached message (30/06/2005) (12 KB) validated by Afssaps. The competent authorities concerned is informed by Afssaps. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

DRUGCHECK
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    ALL DIAG

Manufacturer

ALL DIAG
  • Empresa matriz del fabricante (2017)
    Biosynex
  • Source
    LAANSM