Events

Notificaciones De Seguridad De Campo acerca de Enzygnost Anti-HCV 4.0 on BEP 2000 / BEP 2000 Advance System

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 Siemens Healthcare Diagnostics Products GmbH.

¿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
    2015-06-15
  • 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
    We have observed that in single cases the absorbance value obtained for the enzygnost® anti-hcv 4.0 control, positive on bep 2000 / bep 2000 advance system can be found lower than expected. the occurrence of this issue is triggered by an instrument liquid handling step (conjugate pipetting) in conjunction with enzygnost anti-hcv 4.0. as a precautionary measure we would like to inform you that an enhanced liquid parameter setting is now available for the enzygnost anti-hcv 4.0 method on bep 2000 / bep 2000 advance system. this enhanced setting has been verified internally and leads to a more robust assay performance. there is no change in the assay format, only a minor adjustment of the liquid parameter setting for the enzygnost anti-hcv 4.0 conjugate transfer step. .

Device

Enzygnost Anti-HCV 4.0 on BEP 2000 / BEP 2000 Advance System

Manufacturer

Siemens Healthcare Diagnostics Products GmbH
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    AMPMDRS