Events

Notificaciones De Seguridad De Campo acerca de Stat Profile Prime Analyzers

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 Nova Biomedical Corporation.

¿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
    2017-06-09
  • 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
    Nova biomedical corporation has recently become aware of a software issue on the stat profile prime analyzers listed above when using stat profile prime auto-cartridge quality control (a-qc) materials (also referred to as “onboard quality control” or “internal quality control”). stat profile prime analyzers that do not utilize auto-cartridge quality control materials are unaffected by this software issue. stat profile prime analyzers that only use traditional external quality control materials (glass ampules) are unaffected by this software issue. .

Device

Stat Profile Prime Analyzers
  • Modelo / Serial
    PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG System with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat Profile Prime CCS Comp Analyzer
  • Manufacturer
    Nova Biomedical Corporation

Manufacturer

Nova Biomedical Corporation