Events

Retiro De Equipo (Recall) de Beckman Coulter Unicel DxH 800 Cellular Analysis 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
    19546
  • Fecha de inicio del evento
    2015-12-09
  • 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
    During internal testing, beckman coulter determined that the software for specific systems allows the creation of multiple orders with the same specimen identification (id) but different patient identification when manually editing pending orders at the system manager. the issue does not occur for edits of released results or for test orders requested through host transmission.
  • Acción
    Software to be upgraded

Device

Beckman Coulter Unicel DxH 800 Cellular Analysis System
  • Modelo / Serial
    Model: 629029, B24465, B24802, Affected: , Software version: 3.0.2.0
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc