Retiro De Equipo (Recall) de PF4 IgG assay (Thrombophilia and coagulation inhibitor assay). 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 Diagnostic Solutions 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
    The manufacturer has determined that the pf4 concentrated wash (10x) lots indicated in this letter were manufactured at a slightly more dilute concentration. this may result in slightly increased optical density (positive bias) values with results generated using these buffer lots.
  • Acción
    Diagnostic Solutions is requesting their customers to discard the affected kits. Replacement reagents will be provided. This action has been closed-out on 14/07/2016.


  • Modelo / Serial
    PF4 IgG assay (Thrombophilia and coagulation inhibitor assay). An in vitro Diagnostic Medical Device (IVD).Lot Numbers: 3001992 & 3002227ARTG Number: 217308
  • Manufacturer