Events

Notificaciones De Seguridad De Campo acerca de COBAS TaqScreen MPX Test, version 2.0

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 Roche Diagnostics.

¿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
    2013-11-18
  • Fecha de publicación del evento
    2014-03-01
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2014/01/03/vazno-obavestenje-o-medicinskom-sredstvu-cobas-taqscreen-mpx-test-version-2-0-infektivna-imunologija-reagens/
  • 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 software incorrectly marks the reactive samples as inactive in the presence of curve peaks, instead of declaring the results invalid or correctly marking them as reactive. false non-reactive results can occur from 1 in 26.25 million tests to 1 in 4.09 billion tests. hcv infection can lead to serious adverse events or death if left untreated. however, this only happens in chronic carriers. the possibility of getting hcv infection due to the cobas taqscreen mpx test error, v2.0 is very weak. the curve peaks were also tested for cobas with taqscreen test, v2.0 in channel 2 (hbv), and to a lesser extent in channel 1 (hiv) with data from the european blood bank. in this regard, the possibility of false non-reactive results in channel 1 and 2 cobas with taqscreen mpx test, v 2.0 due to the appearance of peaks on the growth curve is extremely small.

Device

COBAS TaqScreen MPX Test, version 2.0

Manufacturer

Roche Diagnostics