Events

Retiro De Equipo (Recall) de BD Epicenter v6.20A (used in conjunction with Bruker MALDI BioTyper) An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Becton Dickinson Pty Ltd.

¿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
  • ID del evento
    RC-2014-RN-00883-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-08-08
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00883-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Bd epicenter allows for the integration of bd phoenix drug susceptibility results with bruker's maldi biotyper organism identification results within a single id/ast workflow.Bruker updated the maldi biotyper msp database where organism naming changes have been implemented. bd, unaware of these changes, did not implement corresponding changes to the bd epicenter database. this could lead to inconsistency of the orgnaism name between the bd epicenter and bruker maldi biotyper for a limited number of organisms.Bd has performed an analysis of the changes and determined that these inconsistencies either have no relevance to human care (relevant only to plant or animal infection) or have limited impact to human care due to no claims for id or ast in the bd phoenix system.
  • Acción
    BD has developed a tool that will update the relevant data to ensure consistency between the MALDI BioTyper and BD EpiCenter systems after a Bruker MSP database change. This tool will be run by a BD Technical Service representative or can be applied through a remote connection. This action has been closed-out on 01/03/2016.

Device

BD Epicenter v6.20A (used in conjunction with Bruker MALDI BioTyper) An in vitro diagnostic medic...
  • Modelo / Serial
    BD Epicenter v6.20A (used in conjunction with Bruker MALDI BioTyper) An in vitro diagnostic medical device (IVD)Reference number: 441007ARTG number: 222680
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd