Events

Retiro De Equipo (Recall) de BacT / Alert MP

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
    2005-06-09
  • 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-bact-alert-mp-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 June 7, 2005, the company bioMérieux withdrew the lot 1003297 (per 31/08/2005) from the in vitro diagnostic medical device called BacT / Alert MP reference 259797, because this batch is not in conformity with the requirements of the new re-control procedure, internal to the company .. This kit is designed to be used with MB / BacT or BacT / ALERT 3D PLCs for the detection and recovery of mycobacteria in sterile clinical specimens other than the blood and from clinical samples fluidized and decontaminated .. The company has directly notified the recipients of the offending lot by means of the message attached (07/06/2005) (14 KB) validated 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

BacT / Alert MP
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    BIOMERIEUX

Manufacturer

BIOMERIEUX