Events

Retiro De Equipo (Recall) de Grifols Australia AHG Cards

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 Grifols Australia Pty Limited.

¿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
    15381
  • Fecha de inicio del evento
    2013-09-20
  • 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: Grifols Australia Pty Limited, 5/80 Fairbank Road, Clayton South, VIC 3169, AUSTRALIA
  • Causa
    The manufacturer advises that some cards are incompletely sealed. in affected cards this will induce deterioration of the card presentation, resulting in some microwells showing evaporation of the supernatant. this phenomenon can be observed as either a reduction in the gel level or the appearance of cracked gel.
  • Acción
    Product to be destroyed

Device

Grifols Australia AHG Cards
  • Modelo / Serial
    Model: Product Codes: 71300048, 71300504, 71301008, Affected: Lot Number: 13059.01, Expiry: 10/14
  • Manufacturer
    Grifols Australia Pty Limited

Manufacturer

Grifols Australia Pty Limited
  • Empresa matriz del fabricante (2017)
    Grifols Sa
  • Source
    NZMMDSA