Retiro De Equipo (Recall) de BBL GasPak Pouch System;BBL GasPak CamyPouch System

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 BD 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
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  • 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 December 5, 2005, BD Diagnostics removed from the market the batches listed in the attached message, in vitro diagnostic medical devices called BBL GasPak Pouch System reference 260651 and BBL GasPak CamyPouch System reference 260656. devices are pocket systems generating either an atmosphere adapted to the culture of anaerobic bacteria, or an atmosphere adapted to the culture of microaerophilic bacteria. This decision follows the detection of a bacterial contamination of the liquid reagent sachets contained in the aforementioned systems .. The company has directly notified the recipients of the offending lots by means of the message attached (05/12/2005) (69 KB) validated by Afssaps. The competent European authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.


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