Events

Notificaciones De Seguridad De Campo acerca de QMS® Everolimus Immunoassay

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 Thermo Fisher Scientific.

¿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
    2016-10-24
  • 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
    On august 22, 2016 we sent you the below notice on the qms® everolimus immunoassay. since this letter was sent to you additional information has come to light regarding patient samples. originally in the “reason for field action” section we reported that “current patient samples are not in question.” thermo fisher wishes to update that statement to the following: “you may observe bias in patient samples ranging from -15.7% to +5.2% with an average bias of -5.6% when comparing your assay to the lc-ms reference method”. additionally, thermo fisher is also updating the “risk to health” section. the update clarifies that all ranges (sub-therapeutic, therapeutic, supra-therapeutic) may be affected by as much as 16%. .

Device

QMS® Everolimus Immunoassay

Manufacturer

Thermo Fisher Scientific