Events

Retiro De Equipo (Recall) de Siemens Advia Centaur XPT

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Siemens Healthcare Diagnostics Inc.

¿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
    18951
  • Fecha de inicio del evento
    2015-08-03
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, 55 Hugo Johnston Drive, Penrose, Auckland
  • Causa
    Siemens healthcare diagnostics has identified multiple issues with the advia centaur® xpt system software v1.0.1 (bundle 1.0.912 smn 10819704) and v1.0.2 (bundle 1.0.1086 smn 11219806)., when running thcg samples with an initial dilution of 1 to 200, without processing neat specimens, it is potentially possible to miss a positive thcg value where the neat value is less than 1000. a lookback of 48 hours is recommended for negative thcg samples if neat values were not initially run for thcg and large dilutions were employed., there is the extremely unlikely potenial to transpose patient results when running in rack order mode without positive sample identificiation., similarly a lookback of 48 hours for any instruments running in this mode is recommended.
  • Acción
    Software to be upgraded

Device

Siemens Advia Centaur XPT

Manufacturer

Siemens Healthcare Diagnostics Inc
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    NZMMDSA