Events

Retiro De Equipo (Recall) de Conveyor unit (CV-50) of Sysmex XN-9000 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-2018-RN-00501-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-05-24
  • 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-2018-RN-00501-1
  • 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 have been notified by the manufacturer, sysmex corporation, of a potential failure of power up due to a short circuit of the pcb of cv-50 power supply unit in the event a leakage occurs from the instrument or operator error. sysmex have identified that in rare cases, some fluid (approx 50ml) may leak from the xn-10 / xn-20 automated haematology analysers into the conveyor unit itself, resulting in short circuit of the power supply and subsequent malfunction of the conveyor. if this issue occurs, the system will stop and patient samples will require processing by manual measurement.Sysmex has received one complaint worldwide for this issue; none from australian customers to date.
  • Acción
    Roche is advising they will be in contact with customers to arrange for a technician to ensure the gaps on the outer covers of the CV-50 will be sealed with waterproof materials. This will prevent fluid from entering the power supply board.

Device

Conveyor unit (CV-50) of Sysmex XN-9000 automated haematology analysers. An in vitro diagnostic m...
  • Modelo / Serial
    Conveyor unit (CV-50) of Sysmex XN-9000 automated haematology analysers. An in vitro diagnostic medical device (IVD)Material Number: 06510027001ARTG Number: 173886
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited