Events

Notificaciones De Seguridad De Campo acerca de Cryptococcal Antigen Lateral Flow Assay

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 IMMY.

¿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
    2017-01-04
  • 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
    The affected lots’ negative predictive value remains unchanged and is nearly 100%. it is only the positive predictive value that is affected. thus, you may choose to continue to use the affected lots to report negative results and perform alternative confirmatory testing on all positive specimens. however, there are risks associated with this choice. the crag lfa is the most sensitive, commercially-available test for cryptococcal antigen. the risk associated with confirming all positive specimens with a less sensitive test is that true, low titer specimens may be negative using a less sensitive test method. thus, a true, low titer positive specimen may be incorrectly reported as negative. clinical evidence must be used in conjunction with test results. .

Device

Cryptococcal Antigen Lateral Flow Assay
  • Modelo / Serial
    161028142817JH, 161019161504NZ, 161013081750KH, 161003112913JG, 161007110553JG, and 161010145035NZ
  • Manufacturer
    IMMY

Manufacturer

IMMY