Retiro De Equipo (Recall) de IMMULITE/IMMULITE 1000 - Cortisol Assay - 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 identified that immulite/immulite 1000 cortisol kit demonstrate a positive bias with patient samples in the range of approximately 13% to 40%. the positive bias was also observed in quality control materials and may result in values outside the established ranges.. the observed positive bias in cortisol values may potentially lead to additional investigation of adrenal status.
  • Acción
    Siemens are advising users to discontinue use and discard any remaining kits. The issue has been resolved with IMMULITE/IMMULITE 1000 Cortisol kit lots 384 and above (supplied since 1 August, 2014). A look back of previously generated results is at the discretion of laboratory. This action has been closed-out on 12/08/2016.



  • Empresa matriz del fabricante (2017)
  • Source