Events

Retiro De Equipo (Recall) de Siemens ADVIA Centaur Systems, Dimension Vista Systems, IMMULITE Systems

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
    20996
  • Fecha de inicio del evento
    2017-01-09
  • 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
    The manufacturer has confirmed that the presence of dhea-s (a metabolite of dhea, a steroid hormone that may be used as part of in vitro fertilization (ivf) protocols to improve ovarian response and ivf treatment outcomes) causes falsely elevated progesterone results.
  • Acción
    Manufacturer to issue advice regarding use

Device

Siemens ADVIA Centaur Systems, Dimension Vista Systems, IMMULITE Systems
  • Modelo / Serial
    Model: , Affected: ADVIA Centaur Progesterone1 - All Lots, Dimension Vista LOCI Progesterone2 - All Lots, IMMULITE/IMMULITE 1000 Progesterone - All Lots, IMMULITE 2000 Progesterone3 - All Lots
  • Manufacturer
    Siemens Healthcare Diagnostics Inc

Manufacturer

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