Events

Notificaciones De Seguridad De Campo acerca de IMMULITE® 2000 IMMULITE® 2000 XPi

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 Inc..

¿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 immulite 2000®/immulite 2000 xpi® sex hormone binding globulin (shbg) adjustor lots 124 and 125 packed with reagent lots listed in table 1 do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8°c, as published in the instructions for use (ifu). reconstituted adjustors stored at 2-8°c after a two week (14 days) period may show a bias in patient samples and may result in quality control falling outside of established ranges. the reagent lots listed below can exhibit an average bias of 14.5% at day 21 to 16.5% at day 28 (for shbg concentrations of 5 nmol/l to 170 nmol/l) during the open vial adjustor stability period of 30 days. the bias observed was not concentration dependent. .

Device

IMMULITE® 2000 IMMULITE® 2000 XPi
  • Modelo / Serial
    IMMULITE 2000/IMMULITE 2000 XPi SHBG SHBG L2KSH2 10381198 357 2017/01/30 2016/03/08 2016/03/11 IMMULITE 2000/IMMULITE 2000 XPi SHBG SHBG L2KSH2 10381198 358 2017/03/31 2016/05/04 2016/05/06 IMMULITE 2000/IMMULITE 2000 XPi SHBG SHBG L2KSH2 10381198 360 2017/04/30 2016/06/13 2016/06/15
  • Manufacturer
    Siemens Healthcare Diagnostics Inc.

Manufacturer

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