Events

Notificaciones De Seguridad De Campo acerca de B-R-A-H-M-S Free BhCG KRYPTOR

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 Thermo Fisher.

¿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
    2016-02-18
  • 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 to inform you that we observe an overestimation of approximately 10% of free bhcg concentration only in diluted samples or controls when using b-r-a-h-m-s free bhcg kryptor kit lot 09075 or 09073. this may lead to incorrect risk estimation for fetal chromosomal abnormalities. a patient may be considered at higher risk for trisomy 21 or at lower risk for trisomy 13/18. as dilutions are only necessary in samples with very high concentration of free bhcg it is anticipated that only a very small number of patients may be affected by such an error in risk assessment. however, the consequences of additional or different treatment/investigation decisions need to be considered. the impact of an incorrect risk results is mitigated by the fact that free bhcg measurement is not interpreted by its own but only in conjunction with other laboratory and clinical findings as advised by labeling.

Device

B-R-A-H-M-S Free BhCG KRYPTOR

Manufacturer

Thermo Fisher