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 Immucor GmbH..

¿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 099 02 18 000
  • Fecha de inicio del evento
    2018-02-19
  • 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=12176
  • 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
    Immucor, inc. is issuing a product recall notification for ficin solution, lots 661052 and 661055. they have received reports that red blood cells treated with these ficin solution lots may fail to meet the 3 - 4+ reactivity required when testing the ficin-treated red blood cells with the ficin control.

Device

Panocell®-10, Ficin Solution
  • Modelo / Serial
    Ficin Solution, Lot 661052, Exp: 2017-12-28 and Lot 661055, Exp: 2018-04-30 A component of Panocell®-10, Ficin-Treated: - 38310-E, Expired November 24, 2017 - 40332-E, Expired December 08, 2017 - 42355-E, Expired December 22, 2017 - 46089-E, Expired January 19, 2018 - 48110-E, Expires February 02, 2018 - 50135-E, Expires February 16, 2018
  • Descripción del producto
    IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification, Enhancement Media, Enzyme
  • Manufacturer
    Immucor GmbH.

Manufacturer

Immucor GmbH.
  • Empresa matriz del fabricante (2017)
    Ivd Holdings Inc
  • Representante del fabricante
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA