Events

Retiro De Equipo (Recall) de Sysmex XN-Series Automated Haematology Analysers. 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 Roche Diagnostics Australia Pty 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
    RC-2017-RN-00368-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-28
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00368-1
  • 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
    Reports have been received that the sysmex haematology analyser xn-series may generate an intermittent inaccurate low eosinophil count. patient samples analysed by the xn-series analyser reported 0% eosinophils count, but on subsequent manual review, up to 11% eosinophils were observed. this issue may lead to misdiagnosis or delay in treatment for conditions such as allergies or parasitic infections.
  • Acción
    In order to detect the phenomenon, Roche is recommending users set up an Action comment or a Block Validate rule in the Rerun/Reflex/Comment Rule in the IPU settings when certain conditions are met. Users are advised that this action is currently undergoing validation and upon finalisation, a followup notification will be communicated to them. Users are also requested to discuss this matter with their Medical Director.

Device

Sysmex XN-Series Automated Haematology Analysers. An in vitro diagnostic medical device (IVD).

Manufacturer

Roche Diagnostics Australia Pty Limited