Events

translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia 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
    Recall / Field Safety Notice
  • ID del evento
    mdprc 001 07 18 000
  • Fecha de inicio del evento
    2018-07-01
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12833
  • Notas / Alertas
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Roche has confirmed that sample material may potentially come in contact with the pipetting nozzle during operation. the possible presence of biological material on the nozzle has the potential to cause contamination resulting in potential false positive results, depending on the sensitivity of the analytical technology. however, no complaints of false positives have been received from customers. cobas p 612 (63x) (lcp1) systems that use disposable filter tips are not affected by a potential contamination as the filter tips create a physical barrier preventing liquid exposure to the nozzle.

Device

cobas p 612 pre-analytical system (LCP1)
  • Modelo / Serial
    GMMI / Part No: 07563116001 SW Version: All versions from 2.0 and higher
  • Descripción del producto
    IVD, Specimen processing instrument IVD, automated
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics
  • Empresa matriz del fabricante (2017)
    Roche Holding AG
  • Representante del fabricante
    FAROUK, MAAMOUN TAMER & COMPANY
  • Source
    SFDA