Events

Retiro De Equipo (Recall) de QIAsymphony DSP DNA Mini Kits. 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 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
    Recall
  • ID del evento
    RC-2016-RN-00814-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-21
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00814-1
  • 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) in this kit lot contain a reagent cartridge holder with an incorrect shape. one “fixing projection” between well 1 and the bead trough is significantly larger and protruding. this could lead to interrupted runs or incorrect sample processing.
  • Acción
    QIAGEN is advising users to quarantine any remaining stocks of the affected product. Product will be inspected and replaced if affected. QIAGEN is recommending a review of previously generated results. This action has been closed-out on 20/02/2017.

Device

QIAsymphony DSP DNA Mini Kits. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    QIAsymphony DSP DNA Mini Kits. An in vitro diagnostic medical device (IVD).Catalogue number: 937236Lot number: 154023773Reagent cartridge lot number: 154022318 ARTG number: 211651
  • Manufacturer
    Qiagen Pty Ltd

Manufacturer

Qiagen Pty Ltd