Events

Retiro De Equipo (Recall) de UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECKMAN COULTER CANADA L.P..

¿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
    55664
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-11-08
  • 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
    Complaints related to optical degradation have increased on the dxh 800 and dxh 600 systems. customers have reported that they are experiencing an increase in one or more of the following: (1) flow cell clogs (2) ls offset errors during daily check or control analysis (3) high coefficients of variation for latron cp-x controls for low angle light scatter and/or axial light loss parameters (4) system messages and r-flagged results for nrbc diff and retic during control or patient analysis such as partial clogs (low event rated with diff rs) or a voltage failure (system event: d with diff rs).

Device

UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM
  • Modelo / Serial
    Model Catalog: B23858 (Lot serial: ALL); Model Catalog: 629029 (Lot serial: ALL)
  • Descripción del producto
    UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    HC