Events

Retiro De Equipo (Recall) de DxH 500

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
    21476
  • Fecha de inicio del evento
    2017-05-31
  • 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
    The manufacturer has become aware that when the instrument temperature (<18°c to >36.5°c) is exceeded, the dxh 500 allows sample processing and result reporting despite the instructions for use stating that the run sample is inaccessible. results generated in this scenario may be erroneous. additionally:, " the message on the results screen/printout reads instrument temperature instead of instrument temperature out of range., " the results are transmitted to the laboratory information system (lis) without the accompanying instrument temperature out of range message. using the auto-transmit option could lead to the release of erroneous results to the lis.
  • Acción
    Software to be upgraded

Device

DxH 500

Manufacturer

Beckman Coulter Inc