Notificaciones De Seguridad De Campo acerca de Monoclonal Mouse Anti-Human CDX2, Clone DAK-CDX2

Según ALIMS (Agencija za lekove i medicinska sredstva), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Serbia que fue producido por Dako Denmark.

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notas adicionales en la data
  • Causa
    The certificate of analysis ("coa") and the inner pack of "monoclonal mouse anti-human cdx2, clone dak-cdx2" (m3636) contain an error in the protein concentration value of 292.7 mg / l, which is sixteen times greater than the correct concentration. which is 18.3 mg / l. the "monoclonal mouse anti-human cdx2, clone dak-cdx2" (m3636) medical device will perform its function according to the manufacturer's intention, that is, this error does not affect the quality, performance or effectiveness of the medical device. therefore, there is no change in the concentration itself, and the outer packaging indicates the correct concentration of 18.3 mg / l. if the product is diluted with an inaccurate concentration greater than 292.7 mg / l, a diminished color strength will be seen, resulting in poor or negative coloration. this should be easy to detect both in internal positive normal tissue and in recommended positive external process controls. to date, the manufacturer has received only one complaint from the user, who noticed this during testing, and no adverse effects have been reported on any patient.