Events

Alerta De Seguridad para Advia Chemistry Triglycerides _2 Concentrated Re agents (TRIG_c)

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por RANDOX LABORATORIES || Importer: SIEMENS S.A.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    RRD-070316
  • Número del evento
    INVIMA 2014RD-0003060
  • Fecha
    2016-03-15
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=151
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    These batches do not comply with the linearity limit range included in the insert, since the products are close to the end of their useful life. internal tests performed by the parent company showed a bias of -12% to -15%, at concentration levels between 450 to 550 mg / dl, and linearity is reduced by approximately 31% when higher triglyceride concentrations exist, up to 1200mg / dl ( 13.56mmol / l). the above can generate a misinterpretation of very high triglyceride values. however, when considering an alternative treatment, triglyceride values should be used together with other lipid parameters and the patient's medical history.

Device

Advia Chemistry Triglycerides _2 Concentrated Re agents (TRIG_c)
  • Modelo / Serial
    Catalog Reference: 10697575; lots: 348297 and 359932
  • Descripción del producto
    DETERMINATION OF DIFFERENT ANALYTICS RELATED TO SAMPLES FROM THE HUMAN ORGANIZATION
  • Manufacturer
    RANDOX LABORATORIES || Importer: SIEMENS S.A

Manufacturer

RANDOX LABORATORIES || Importer: SIEMENS S.A