Events

Retiro De Equipo (Recall) de XN-L series analyser

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 Sysmex Corporation.

¿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
    21663
  • Fecha de inicio del evento
    2017-07-05
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 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: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Causa
    It has been reported that the wbc could become falsely low when the following steps are performed:, manual mode is selected, whole blood mode (wb), predilute mode (pd) or body fluid mode (bf) is changed to low wbc mode (lw)., the measurement information is input in the manual order dialogue and the menu is closed by selecting 'ok'., no measurement is performed in lw mode, and the mode is then changed to use another measurement mode (ie either wb, pd, bf)., with the next measurement, the wbc result becomes diluted and gives a result half of the correct wbc value.
  • Acción
    Software to be upgraded

Device

XN-L series analyser
  • Modelo / Serial
    Model: , Affected: XN-L series instruments: version 00-13 and above
  • Manufacturer
    Sysmex Corporation

Manufacturer

Sysmex Corporation