Events

Notificaciones De Seguridad De Campo acerca de UniCel DxH 800 Coulter Cellular Analysis System 629029, B24465, B24802, B68304, B66445, B63322 All UniCel DxH 600 Coulter Cellular Analysis System B23858 All

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Beckman Coulter, Inc. .

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-04-24
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. the events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result. in most cases, system flags and/or messages have accompanied the erroneous results, indicating the need to review the results. in rare instances, system flags and/or messages might be absent. .

Device

UniCel DxH 800 Coulter Cellular Analysis System 629029, B24465, B24802, B68304, B66445, B63322 Al...

Manufacturer

Beckman Coulter, Inc.