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 DiaMed 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 068 06 13 000
  • Fecha de inicio del evento
    2013-06-16
  • 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=3751
  • 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
    In some specific conditions, inconsistent grading between the results in the well/card and the results returned by the ih-1 000 may be observed. after deep investigations, confirm that in these very specific conditions, positive reactions might be read as negative by the system due to the analysis algorithm of the images. therefore, this issue might lead to a wrong result released to the host if all the 3 following conditions are met: 1. a result is returned as negative while the reaction is positive, dp, or requires a human interpretation . 2. this negative result is consistent with the global interpretation of the test. 3. the system is configured without the second reading function activated for all tests results.

Device

IVDs,blood transfusion instrumentation, IH-1000
  • Modelo / Serial
    Product name: IH-1000 Product REF: 001000 IH-1000 software version: All version
  • Descripción del producto
    IVDs, blood transfusion instrumentation
  • Manufacturer
    DiaMed GmbH

Manufacturer

DiaMed GmbH
  • Empresa matriz del fabricante (2017)
    Bio-Rad Laboratories Inc
  • Representante del fabricante
    Al Nahir Trading co , Riyadh , (011)4770444
  • Source
    SFDA