Events

Retiro De Equipo (Recall) de Beckman Coulter DxH Cleaner

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 Beckman Coulter 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
    15774
  • Fecha de inicio del evento
    2013-11-29
  • 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: Beckman Coulter NZ Ltd, Suite 2, Level 4, 30 St Benedicts Street, Newton, AUCKLAND
  • 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:, * 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).
  • Acción
    Instructions for use to be updated

Device

Beckman Coulter DxH Cleaner
  • Modelo / Serial
    Model: Part Numbers: 628022, 628023, Affected: 12 specific lots
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc