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 Abbott.

¿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 067 12 17 000
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Abbott has identified that falsely elevated results may be obtained when using the architect dhea‐s assay with samples from infants up to 60 days old. the specific cause of the elevated results is currently under investigation.


  • Modelo / Serial
    Product Product Name List Number Lot Number UDI ARCHITECT DHEA‐S Reagents 8K27‐20 01316K000 (01) 00380740017446 (17) 180204 (10) 01316K000 (240) 8K2720 01217A000 (01) 00380740017446 (17) 180413 (10) 01217A000 (240) 8K2720 02217D000 (01) 00380740017446 (17) 180624 (10) 02217D000 (240) 8K2720 04117H000 (01) 00380740017446 (17) 181125 (10) 04117H000 (240) 8K2720 ARCHITECT DHEA‐S Reagents 8K27‐25 01216K000 (01) 00380740017453 (17) 180204 (10) 01216K000 (240) 8K2725 01117A000 (01) 00380740017453 (17) 180413 (10) 01117A000 (240) 8K2725 02217C000 (01) 00380740017453 (17) 180617 (10) 02217C000 (240) 8K2725 02317D000 (01) 00380740017453 (17) 180624 (10) 02317D000 (240) 8K2725 02417D000 (01) 00380740017453 (17) 180624 (10) 02417D000 (240) 8K2725 00517F000 (01) 00380740017453 (17) 180902 (10) 00517F000 (240) 8K2725 02817H000 (01) 00380740017453 (17) 181021 (10) 02817H000 (240) 8K2725
  • Descripción del producto
    IVD Test Reagent/Kits, Immunoassay
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Representante del fabricante
    Medical supplies & Services Co.Ltd Mediserv
  • Source