Retiro De Equipo (Recall) de Bond Polymer Refine Red Detection System. An in vitro diagnostic medical device (Immunohisto chemical staining kit)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Leica Biosystems Melbourne 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Leica biosystems has received reports that the product may be contaminated with fungus. this issue could cause loss of staining sensitivity or obstruction of fluid delivery to the slide.
  • Acción
    Leica Biosystems is requesting users to remove and discard remaining affected reagents. Affected product will be replaced by Leica Biosystems. A review of patient results reported from the affected lot should be undertaken at the discretion of the laboratory manager.


  • Modelo / Serial
    Bond Polymer Refine Red Detection System. An in vitro diagnostic medical device (Immunohisto chemical staining kit)Catalogue Number: DS9390Lot Numbers: 22017
  • Manufacturer