Events

Retiro De Equipo (Recall) de RANGE CHECK X II

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SYSMEX CANADA 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
    87321
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-02-12
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Sysmex america inc. received complaints from sysmex installation specialists and customers that level 2 of the five levels of white blood cell (wbc) linearity of range check xii (rcxll) was recovering above the expected range on the poch-1 ooi xp-300 and kx-21 n and kx-21 analyzers (three-part differential analyzers). level 2 wbc recovery is expected to be approximately 0.5 +/- 0.5 x103/ul and recovery was above 1.0 x103/ul in some instances. when the recovery is above 1.0 the plotted line is not straight suggesting the analyzer is not linear through the entire wbc reportable range of 1.0 to 99.9 x103/ul for the three part differential analyzers. exclusion of the level 2 produces a linear graph.

Device

RANGE CHECK X II
  • Modelo / Serial
    Model Catalog: 130-4003-0 (Lot serial: 5006 5076); Model Catalog: 130-4003-0 (Lot serial: 4091 4161 4231 4301)
  • Descripción del producto
    Range Check X II
  • Manufacturer
    SYSMEX CANADA INC.

Manufacturer

SYSMEX CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Sysmex Corp.
  • Source
    HC