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 BD.

¿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 078 10 18 001
  • Fecha de inicio del evento
    2018-11-06
  • 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=13453
  • 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 , FDA
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Bd has confirmed that a limited number of bd max™ systems were manufactured with purchased optical filters that have shown a potential to produce a false positive result for candida glabrata when processing samples positive for trichomonas vaginalis during testing with the bd max™ vaginal panel. if the bd max vaginal panel was successfully verified/validated using the contrived zeptometrix vaginal panel control panel, the risk of reporting a clinical false positive c.Glabrata result is low. the reported c. glabrata false positive results were all identified by customers when using the control material.

Device

BD MAX System
  • Modelo / Serial
    Catalog No.: 441916 Multiple serial numbers of the affected device are provided in the attached FSN. ................................................................. FDA update codes: BD Max Instrument, Catalog Number 441916 441927 Serial Numbers: CTI1201-CTI1288 Catalog Number 8090369/443364, 44336409 Serial Numbers: 079577 to 079896, 78154, 78503, 78363, 78321, 78584, 78840, 78975, 78711, 77048, 79783, 78857, 79162, 78387, 78182, 78832, 78905, 77062, 78856, 78352, 78903, 78667, 78665, 78928, 78986, 77108, 77543, 78615, 78481, 77373, 77707, 78927
  • Descripción del producto
    IVD Test Reagent/Kits
  • Manufacturer
    BD

Manufacturer

BD