Events

Notificaciones De Seguridad De Campo acerca de DIASTAT ANA ELISA kit

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 Euro Diagnostica AB.

¿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
    2017-02-15
  • 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
    The reason for this field safety notice is that the affected kit lot ts 2076 of diastat ana elisa is at risk of malfunctioning due to an unstable conjugate. testing of retain material at euro diagnostica with a sample panel from healthy donors showed that there was an increased risk for equivocal sample results with the ana lot ts 2076. investigation suggests that the igg conjugate is unstable over time and the shelf-life of the product cannot be guaranteed. there is a risk that users get false positive test results. this is a product malfunction. however based on the product information to customers, there is a risk that treatment may be started up based on a false positive result, which could be critical for patient health and safety. .

Device

DIASTAT ANA ELISA kit

Manufacturer

Euro Diagnostica AB