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 Bio-Rad Medical 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 063 07 17 000
  • Fecha de inicio del evento
    2017-07-17
  • 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=11308
  • 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
    It has come to our notice that for product id-papain, mal n° 005510, shows double population reactions when the auto-control is performed in papain one stage technique. it has been observed internally that in the last two weeks before expiry, the lots of papain mentioned above may not destroy these antigens as expected. there is no patient risk associated with this issue. the use of id-papain for compatibility testing and for the detection of antigens normally detected in the id-papain test is not impacted by this phenomenon and the papain can be used for this purpose.

Device

ID-Papain
  • Modelo / Serial
    Double population reaction Mat. n° : 005510 Loss of enzyme activity Mat. n° : 005510 Lot No IHD : 06311 961, 06311 97 1, 06311 991, 06311 02 1 Lot No SAP : 121302961, 124782971, 141517991, 145832021 Expiry Date : 03.07.2017, 17.07.2017, 31.07.2017, 14.08.2017
  • Descripción del producto
    Immunohematology, ID-Papain
  • Manufacturer
    Bio-Rad Medical Diagnostics

Manufacturer

Bio-Rad Medical Diagnostics
  • Empresa matriz del fabricante (2017)
    Bio-Rad Laboratories Inc
  • Representante del fabricante
    ABDULREHMAN AL GOSAIBI GTB
  • Source
    SFDA