Events

Notificaciones De Seguridad De Campo acerca de cobas p 512 pre-analytical system (64x) and cobas p 612 pre-analytical system (63x)

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 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
  • 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
    Roche diagnostics received complaints from two customers that un-spun samples were incorrectly identified as “spun” by the spin status detection on cobas p 512 (64x) pre-analytical system. when non-centrifuged samples incorrectly identified as “spun” are further analyzed, erroneous results may occur and relevant medical risk cannot be entirely excluded. this case made us aware that we need to provide a better specification on the intended use of the spin status detection. the cobas p 512 (64x) and the cobas p 612 (63x) systems are not designed to make a sorting decision based on the spin status detection functionality. while investigating these complaints, we identified that all documentation related to .

Device

cobas p 512 pre-analytical system (64x) and cobas p 612 pre-analytical system (63x)
  • Modelo / Serial
    All cobas p 512 (64x) pre-analytical system All cobas p 612 (63x) pre-analytical system
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics