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 Gen Probe Incorporated.

¿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 140 09 12 000
  • Fecha de inicio del evento
    2012-09-17
  • 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=5&rid=2395
  • 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: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Anomalous decreases in the average optical density (00) have been observed with certain kits within the llfecode5 pak product line. we believe the decrease in od was caused by a chemical reaction with an unknown compound that was introduced into the manufacturing process when faulty vials supplied by a third party were used to contain the substrate buffer kit component.

Device

IVD, detection of autoantbodies LIFECODES PAK12, PAKAUTO & PAK2-LE
  • Modelo / Serial
    Catalogue number: PAK12, PAKAUTO & PAK2-LE (see attached)
  • Descripción del producto
    IVD, detection of autoantbodies LIFECODES
  • Manufacturer
    Gen Probe Incorporated

Manufacturer

Gen Probe Incorporated
  • Empresa matriz del fabricante (2017)
    Grifols Sa
  • Representante del fabricante
    Al-Jeel Medical & Trading Co. Ltd, Riyadh, (01) 4041717
  • Source
    SFDA