Events

Retiro De Equipo (Recall) de Beckman Coulter UniCel system

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
    21324
  • Fecha de inicio del evento
    2017-10-25
  • 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
    In april 2017 the manufacturer issued an urgent medical device recall. as a follow up to this notification, the access br monitor instructions for use (ifu) will be updated. the updated ifu will reflect the 95th percentile upper reference limit (url) value for a healthy population, which was determined to be 23.5 u/ml. there is no change to the access br monitor assay.
  • Acción
    Manufacturer to issue advice regarding use

Device

Beckman Coulter UniCel system
  • Modelo / Serial
    Model: , Affected: UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i systems.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc