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 069 05 13 000
  • Fecha de inicio del evento
    2013-05-20
  • 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=3624
  • 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
    An error relative to the liquid reagents management (test cells or anti-serum vials) might occur if the following conditions are present: 1. ih-1000 is in status "ready to start" and, 2. the user requests the unloading of a reagent rack while the system is creating the internal batch, the time slot during which the error could occur is about 2 seconds. 3. another rack is loaded immediately afterwards in the same position. if all three conditions are present, the ih-1000 may not use the full set of liquid reagents required to perform the tests of the ongoing batch. due to a software failure, the system may only use the vial placed in the first position of the re-ioaded rack for all the tests of the ongoing batch.

Device

IVDs, blood transfusion instrumentation , IH-1000
  • Modelo / Serial
    Cat.No.001000 SW version : All SN : see attached
  • Descripción del producto
    Fully Automated Blood Grouping Machine IH-1000
  • 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