Events

Retiro De Equipo (Recall) de Slidex Rota-Kit 2

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 BIOMERIEUX.

¿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
    2006-04-04
  • 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-de-lots-du-dmdiv-slidex-rota-kit-2-biomerieux
  • 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 31 March 2006, bioMérieux withdrew from the market batches 50608 B (per 10/08/2006), 50608 C (per 10/08/2006), 50609 (per 10/08/2006) and 60165 21/02/2007) of the in vitro diagnostic medical device called Slidex Rota-Kit 2, reference 58842. This device is a rapid card agglutination test of latex particles for the qualitative detection of rotavirus in human stool. . This measure follows the identification of a decrease in sensitivity that could lead to false negative results. The company has directly notified the recipients of the offending lots by means of the attached message (04/04/2006) (25 KB) validated by Afssaps. The relevant European competent authorities 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

Slidex Rota-Kit 2
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX