Retiro De Equipo (Recall) de QIAsymphony DSP Virus/Pathogen Midi Kit. An in vitro Diagnostic Medical Device (IVD)(DNA/RNA purification system)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Qiagen 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
    Some reagent cartridges (reag cart) of this kit lot contain reagent troughs that are not filled correctly. this leads to decreased quality of the resulting nucleic acids.
  • Acción
    End users are advised to discard any remaining affected lots of QIAsymphony DSP Virus/Pathogen reagent. It is also recommend that results from samples processed on the QIAsymphony using the affected reagent are reviewed. This action has been closed-out on 15/07/2016.


  • Modelo / Serial
    QIAsymphony DSP Virus/Pathogen Midi Kit. An in vitro Diagnostic Medical Device (IVD)(DNA/RNA purification system)Lot Number: 148028163
  • Manufacturer