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 Siemens Healthcare Diagnostics.

¿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 07 18 000
  • Fecha de inicio del evento
    2018-07-11
  • 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=12904
  • 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
    Siemens healthcare diagnostics has received customer complaints regarding dimension vista® loci® reaction vessels causing vessel pickup errors. supplier internal investigation has identified the potential for a loci reaction vessel to contain a small hole or indent on the top of the vessel. this may result in the vista system generating a “vessel pickup error” when the defective vessel is not successfully picked up by the vacuum system. the error is resolved when the defective vessel is removed from the system.

Device

Dimension Vista LOCI Reaction Vessels
  • Modelo / Serial
    Catalog Number: KS855 Siemens Material Number: 10445212 Lot Number: All lots prior to lot NH3912618 First Shipment Date: 2018-05-10
  • Descripción del producto
    IVD Test Reagent/Kits, Immunoassay
  • Manufacturer
    Siemens Healthcare Diagnostics

Manufacturer

Siemens Healthcare Diagnostics
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Representante del fabricante
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA