Events

Retiro De Equipo (Recall) de Dimension Vista 500 & Dimension Vista 1500 Analysers with Software versions 3.4 or 3.5.1 ( 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 Siemens Ltd Diagnostics Division.

¿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-00520-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-24
  • 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-00520-1
  • 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
    Siemens has confirmed that there is potential for the vial volume of "in use" vista calibrators, controls or sample diluent to incorrectly revert to full volume when removed and reloaded.If vista vials revert to full volume, insufficient volume may result in the following:- calibrator vial – failed calibration- control vial – low out of range qc- sample diluent vial – auto-diluted results will flag with an above assay range error or a falsely elevated diluted result above the assay range will occur for the following methods: ctni, e2, or tsh.
  • Acción
    Siemens is providing temporary work around instructions and is in the process of implementing Vista software version 3.6. Siemens is planning to send additional communication to customers when the software is available.

Device

Dimension Vista 500 & Dimension Vista 1500 Analysers with Software versions 3.4 or 3.5.1 ( An in ...
  • Modelo / Serial
    Dimension Vista 500 & Dimension Vista 1500 Analysers with Software versions 3.4 or 3.5.1 ( An in vitro diagnostic medical device (IVD))Siemens Material Numbers: 10488224, 10444802ARTG Number: 174699
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA