Events

Retiro De Equipo (Recall) de STA - Liatest vWF: Ag assay used with the STA-R/STA-R EVOLUTION analyser. An in vitro diagnostic medical device (IVD) for the measurement of von Willebrand factor.

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Diagnostica Stago 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-2013-RN-00042-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-01-17
  • 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-2013-RN-00042-1
  • 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
    Diagnostica stago has confirmed that the sta - liatest vwf: ag assay may produce falsely low results when testing some qc and patient samples.
  • Acción
    Stago are advising users to confirm all results obtained in the abnormal range (under 50%) with a manual rerun or by the creation of a dependant test at a 1:2 dilution until a corrective action has been determined. If tests are already performed in duplicate, the requirement for follow up testing should be at the discretion of the laboratory manager.

Device

STA - Liatest vWF: Ag assay used with the STA-R/STA-R EVOLUTION analyser. An in vitro diagnostic ...
  • Modelo / Serial
    STA - Liatest vWF: Ag assay used with the STA-R/STA-R EVOLUTION analyser. An in vitro diagnostic medical device (IVD) for the measurement of von Willebrand factor.Ref: 00518ARTG: 185170
  • Manufacturer
    Diagnostica Stago Pty Ltd

Manufacturer

Diagnostica Stago Pty Ltd