Events

Retiro De Equipo (Recall) de Sysmex XN-10 and XN-20 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-00585-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-18
  • 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-00585-1
  • 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
    Roche diagnostics australia has been informed by sysmex asia pacific that misalignment of the protective sheet on sysmex xn-10 and xn-20 analysers may allow potential leakage from fluidic parts to reach the electronic components. this leakage has the potential to result in the build-up of salt deposits on the electronic components which over time may present an internal combustion hazard.There has been one complaint worldwide relating to this issue. to date, no complaints have been received in australia.
  • Acción
    Roche Diagnostics is advising customers that during the next immediate future service visit the technician will check the positioning of the protective sheet and verify that there is no leakage from the fluidic parts. If necessary, re-routing of the wiring bundle will be performed to eliminate interference and affected components replaced. In the interim, customers are requested not to attempt to inspect their instruments themselves as this area of the instrument is inaccessible to them.

Device

Sysmex XN-10 and XN-20 Automated Haematology Analysers. An in vitro diagnostic medical device (IVD)

Manufacturer

Roche Diagnostics Australia Pty Limited