Retiro De Equipo (Recall) de Siemens Dimension Vista Theophylline reagent cartridge

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
    13242
  • Fecha de inicio del evento
    2012-08-01
  • País del evento
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
  • 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
    Manufacturer confirms that it has received complaints from customers of "abnormal reaction" errors occurring on calibrations, qa and patient samples. the abnormal reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation. manufacturer advises that results reported with the abnormal reaction flag are acurate, however per the vista operator's guide, flagged results should not be reported and should be repeated. this is considered no health risk.
  • Acción
    Product to be destroyed

Device

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    NZMMDSA