Events

Notificaciones De Seguridad De Campo acerca de Captia Syphilis IgG 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 Trinity Biotech.

¿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
    2016-11-03
  • 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
    Trinity biotech was informed of a customer's concern about the possible under-abundance of red in positive high titre control. the color is not the same with all kits as some vials may be red and some may be colorless. the investigation showed that the color red was fading. in addition, trinity performed performance tests on both red and colorless high titre positive control vials and found that the kit continued to meet all quality assurance criteria for batch release. the absence of color does not affect the performance of a kit that meets all the criteria for performing a valid test. the color red is inert and is usually added for visual distinction.

Device

Captia Syphilis IgG Kit

Manufacturer

Trinity Biotech