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 Abbott.

¿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 083 11 17 000
  • Fecha de inicio del evento
    2017-11-23
  • 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=11787
  • 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 cell-dyn ruby allows the display of parameter results in usa, international system of units (si), modified international system of units (si mod), unit set 1 or unit set 2 per user configuration. abbott has identified the following issue related to unit set selection for celldyn ruby analyzers using system software versions 2.2ml and lower: standard deviation (sd) values for select parameters (refer to table a) in the qc views only (qc-qcid data view and qc-levey jennings) will be incorrectly displayed when unit sets other than the usa unit are selected on the cell-dyn ruby. these units are incorrectly converted from usa units to other unit sets for display purposes. means, percent cv, and limit (upper and lower) information in qc views are correct. in addition, instrument flagging, alerts, and results are correct for all unit sets.

Device

CELL-DYN Ruby
  • Modelo / Serial
    List Number: 08H67-01; 08H67-03 Serial Numbers: All serial numbers below 70594BG UDI: 00380740017170; 00380740099916
  • Descripción del producto
    CELL-DYN Ruby
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Representante del fabricante
    Medical supplies & Services Co.Ltd Mediserv
  • Source
    SFDA