Events

Notificaciones De Seguridad De Campo acerca de Elecsys® Anti-HAV

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 Roche Diagnostics.

¿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
  • 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
    When li-heparin and na-heparin plasma specimens were compared to serum samples during internal investigations the specified required recovery could not be achieved. values determined with these types of plasma specimens were found to be on average up to 35% below those obtained in serum. false low recovery of samples is likely to occur only for heparin plasma samples within close proximity to the medical decision point of the assay at 20 iu/l. based on internal data generated by testing 4000 blood donors and routine samples approx. 0.1% of samples were close to the cut-off of 20 iu/l. .

Device

Elecsys® Anti-HAV

Manufacturer

Roche Diagnostics