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 BioMerieux Inc..

¿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 028 07 18 000
  • Fecha de inicio del evento
    2018-07-05
  • 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=12860
  • 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
    The bact/alert® virtuo® instrument firmware version r2.0 allows relocation of the four (4) resident calibration standards so that field system engineers (fse) can service the associated cells p24 - p27, where the calibration standards typically reside. if the calibration standards are not returned to the designated locations, an anomaly may occur. following a reboot via the instrument’s small user interface screen, while patient or test bottles are loaded in cells p24 - p27, the following will occur: 1. the unload date/time will be set to the current date/time, causing the bottle status to be set to “unload” even though the bottle remains in the instrument. 2. the bottle will continue to process; however, in the event of a positive bottle in cells p24 – p27, no indication of a positive bottle will be observed by the user. neither the visual (flashing yellow light) nor audible alarm will occur. 3. although the instrument does not provide alarm to the user, the bottle result (positive or negative) is transferred to the lis (laboratory information system). two consecutive error conditions may also be observed for bottles in cells p24 – p27: 1. an “anonymous bottle” alarm. 2. a “duplicate bottle” alarm. to prevent this anomaly from occurring, your local field service engineer (fse) has confirmed the calibration standards are in the designated bottle cell locations.

Device

BACT/ALERT® VIRTUO® Microbial Detection System
  • Modelo / Serial
    Reference: 411660, 411661, 419947 All serial numbers are impacted
  • Descripción del producto
    Analyzers, Laboratory, Microbiology, Blood Culture, Automated
  • Manufacturer
    BioMerieux Inc.

Manufacturer

BioMerieux Inc.
  • Empresa matriz del fabricante (2017)
    Compagnie Merieux Alliance
  • Representante del fabricante
    Al-Jeel Medical & Trading Co. LTD
  • Source
    SFDA