Events

Retiro De Equipo (Recall) de BBL DrySlide Kit

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por BD Medical (USA).

¿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
    14555
  • Fecha de inicio del evento
    2013-04-23
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Becton Dickinson Ltd, 14B George Bourke Drive, Mt Wellington, Auckland 1060
  • Causa
    The dryslide oxidase is used for determining the oxidase reaction of bacteria., during the manufacturing process, portions of the test slides were placed into the incorrect product packaging. this could result in intermittent quality control and false results (the dryslide oxidase is used for determininh the oxidase reaction of bacteria).
  • Acción
    Product to be returned to supplier

Device

BBL DrySlide Kit
  • Modelo / Serial
    Model: 231746, Affected: 2222008
  • Manufacturer
    BD Medical (USA)

Manufacturer

BD Medical (USA)