Events

Retiro De Equipo (Recall) de Beckman Coulter UniCel DxC Synchrom Systems No Foam Reagent

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
    20362
  • Fecha de inicio del evento
    2016-07-06
  • 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
    An iincompatibility between no foam dxc reagent (ref b64130) and the dxc hydropneumatic parts associated with no foam delivery has been identified., dxc no foam reagent is intended to prevent formation of foam and/or bubbles in the dxc waste system of the hydropneumatic subsystems. over time, this incompatibility may lead to:, - breaks in no foam cap assembly, - cracks in no foam waste collector; and, - seepage outside no foam tubing, this issue may lead to cracks in the waste collector which may stop instrument operation due to vacuum error, and potentially lead to biohazardous waste exposure.
  • Acción
    Manufacturer to issue advice regarding use

Device

Beckman Coulter UniCel DxC Synchrom Systems No Foam Reagent

Manufacturer

Beckman Coulter Inc