Retiro De Equipo (Recall) de COULTER DXH DILUENT

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
  • ID del evento
  • Clase de Riesgo del Evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • 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
    Beckman coulter has confirmed an increased number of complaints related to hemoglobin (hgb) on the unicel dxh 800 and dxh 600 coulter cellular analysis systems. the investigation has revealed that the issues may be related to variability in components of the coulter dxh diluent. the use of the dxh diluent (lot numbers 3099980 - 3512190) may eventually result in a compromised hgb chamber. the use of the dxh diluent lots listed in this notice may eventually result in a compromised hgb chamber indicated by the occurrence of events listed in the issue section. the hgb chambers are being replaced on an as needed basis. sporadic but incorrect hgb results may be observed if your system's hgb chamber is compromised. the issue is not observed with all dxh 800 and dxh 600 systems.


  • Modelo / Serial
    Model Catalog: 628017 (Lot serial: 3099980 - 3512190)
  • Descripción del producto
  • Manufacturer


  • Dirección del fabricante
  • Empresa matriz del fabricante (2017)
  • Source