Events

Retiro De Equipo (Recall) de Siemens Immulite 2000/ Immulite 2000 xPi IGF-1

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 Products Limited.

¿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
    13811
  • Fecha de inicio del evento
    2012-11-19
  • 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, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    The manufacturer has confirmed a positive shift in patient medians of approximately 20% with the igf-1 assay. siemens has determined that an initial positive shift of approximately 15% occcurred with immuliate 2000/ immulite 2000 xpi and an additiional positive shift of approximately 5% was observed with immulite 2000/ immulite 2000 xpi leading to the total positive shift of approximately 20%., two potential health risks:, 1. could mask uncontrolled acromegaly and thus affect patient treatment., 2. could lead to an under estimation of hgh deficiency in children with borderline hgh deficiency and potentially result in missed or delayed opportunity to treat with hgh supplement.
  • Acción
    Manufacturer to issue advice regarding use

Device

Siemens Immulite 2000/ Immulite 2000 xPi IGF-1

Manufacturer

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