Events

Notificaciones De Seguridad De Campo acerca de Dimension® EXL™ integrated chemistry system Dimension Vista® System Dimension EXL TNI, Dimension Vista DIGXN, E2, FERR, PRL, TSH

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 Limited.

¿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
  • 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
    Siemens healthcare diagnostics has confirmed that the concentrations for biotin listed in the non-interfering substances section of the current dimension and dimension vista instructions for use for dimension tni, dimension vista digxn, e2, ferr, prl, tsh have incorrect units, and incorrectly state the level at which biotin does not interfere. in the cases of tni, e2, ferr, prl, and tsh, there is significant interference at the levels incorrectly stated in the current ifu. dv e2, a competitive assay, exhibits a positive bias while the other methods (sandwich assays) exhibit a negative bias. digxn si units for biotin are incorrect by a factor of 100 lower than the level at which biotin does not interfere, in the current ifu.Dimension (dm) and dimension vista (dv) affected product.

Device

Dimension® EXL™ integrated chemistry system Dimension Vista® System Dimension EXL TNI, Dimension ...

Manufacturer

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