Retiro De Equipo (Recall) de UniCel DxH 600 & 800 Coulter Cellular Analysis System. 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 Beckman Coulter Australia Pty Ltd.

¿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
    Class I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Update: beckman coulter's investigation has shown that the dxh cleaner were the main contributor to the optical degradation issue.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:- flow cell clogs (::::)- ls offset errors during daily check or control analysis- high coefficients of variation (cv) for latron cp-x controls for low angle light scatter (lals) and/or axial light loss (all) parameters- 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)the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells, white blood cell differential and/or reticulocytes.
  • Acción
    Update: Beckman Coulter is requesting their customers to discard the affected lot of DxH Cleaner. Laboratories can discontinue the additional flush flow cell and cleaning actions. Beckman Coulter is recommending users perform a Flush Flow Cell, Extended Cleaning and perform a routine shutdown at least daily. A permanent fix will be implemented when available.


  • Modelo / Serial
    UniCel DxH 600 & 800 Coulter Cellular Analysis System. An in vitro diagnostic medical device (IVD)UniCel DxH 600 Coulter Cellular Analysis SystemPart Number: B23858UniCel DxH 800 Coulter Cellular Analysis SystemPart Number: 6290029
  • Clasificación del producto
  • Manufacturer