Events

Retiro De Equipo (Recall) de BBL Crystal Enteric/Non-fermenter ID Kit, 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-2013-RN-00004-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-01-08
  • 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-2013-RN-00004-1
  • 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
    Becton dickinson has determined that these products have the citrate (cit) and malonic acid (mlo) reagents in the reversed prong/well positions. this may lead to no-identification or multiple identification choices. customers specifically reported split identification results between citrobacter and salmonella, however other bacterial identifications requiring the use of these two substrates may be affected.
  • Acción
    Becton Dickinson Pty Ltd is advising customers to discontinue use and discard any affected product. Replacement product or credit will be provided for any discarded product.

Device

BBL Crystal Enteric/Non-fermenter ID Kit, An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    BBL Crystal Enteric/Non-fermenter ID Kit, An in vitro diagnostic medical device (IVD)Catalogue number: 245000Lot number: 2129487Expiration date: 13 March 2013
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd