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 Diagnostica Stago.

¿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 056 11 18 000
  • Fecha de inicio del evento
    2018-11-20
  • 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=13504
  • 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
    Stago has informed that several customers have reported shortened (t1-t2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds for sta-control la2 have been observed (this range is specified on the kit value sheet). the subsequent root cause investigations have found that the issue is due to a sensitivity decrease which occurs towards the end of the respective lot number's shelf life. we have found this to be related to the material used for manufacturing the stoppers used only for the buffer and solvent vials. according to guidelines of the isth ssc anti phospholipids syndrome, several tests should be performed to detect and confirm the presence of la. hence, previously released patient results should not need to be re-assessed. there have been no reports of injury in relation to this issue.

Device

STACLOT LA (REF. 00600).
  • Modelo / Serial
    Lot Number: 251918 Expiry: 31 March 2019 Lot Number: 252751 Expiry: 30 September 2019
  • Descripción del producto
    An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Diagnostica Stago

Manufacturer

Diagnostica Stago
  • Empresa matriz del fabricante (2017)
    Stago International
  • Representante del fabricante
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA