Events

Retiro De Equipo (Recall) de Dimension Vista 500 and 1500 Intelligent Lab System. 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-2015-RN-00430-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-20
  • 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-2015-RN-00430-1
  • 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
    Issue 1: samples may stop processing without notification on the dimension vista 500 or dimension vista 1500. this issue is due to a failure to exchange aliquot plates, causing the lane to become unavailable. issue 2:complaints were received on the dimension vista 1500 for a series of unexpected results, some of which were not flagged with errors or results that were flagged with errors. it has been determined that under a rare set of conditions, a timing issue may cause a reagent server to temporarily lose synchronisation during the automatic removal of reagent cartridges from reagent server 2 to waste a container. in the extremely unlikely circumstance that this issue occurs, a flag will be generated for the majority of assays. however, there is the potential to produce unflagged erroneous but believable results for some assays.
  • Acción
    Users are provided with temporary workarounds in the customer letter. Siemens will be providing corrections for the issues in a future Vista software version. Review of previously generated results due to this issue is at the discretion of laboratory. This action has been closed-out on 26/08/2016.

Device

Dimension Vista 500 and 1500 Intelligent Lab System. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Dimension Vista 500 and 1500 Intelligent Lab System. An in vitro diagnostic medical device (IVD)Software version: 3.6.1, 3.6.1_MU3p and 3.6.1SP1ARTG Number: 174699
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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