Events

Alerta De Seguridad para ADVIA Tnl -ULTRA

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 SIEMENS HEALTHCARE DIAGNOSTICS INC || 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
    IRD-070516
  • Número del evento
    INVIMA 2007RD-0000558
  • Fecha
    2016-05-18
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=140
  • 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
    Change in the results greater than 10% in samples with biotin levels of up to 10 ng / ml (41 nmol / l). the test insert states that samples containing up to 10ng / ml (41 nmol / l) of biotin show a change in results of less than or equal to 10%. the level of biotin in the general population is approximately 0.3 to 1.0 ng / ml (1.2a 4.3 nmol / l). internal research at siemens has shown changes in tni-ultra concentrations in samples with biotin concentrations of 1.0 ng / ml, 2.5 ng / ml, 5 ng / ml, 10 ng / ml and 20 ng / ml. however, no impact on diagnosis or treatment is expected, as the ability of the trial to detect increases or decreases in troponin is not affected.

Device

ADVIA Tnl -ULTRA
  • Modelo / Serial
    Catalog 02789602, SMN 10317708, lots: 24483099, 28137099, || 36527099, 42516099, 46626101, 59655103, 53539104, || 72936105, 81676105, 89385106, 94642106 || C atogue 02790309, SMN: 10317709, lots: 24479099, || 26294099, 43205101, 46929101, 57805103, 65432103, || 52590104, 73322105, 80480105, 86319106, 94250106
  • Descripción del producto
    REAGENTS, CONTROLS AND CALIBRATORS USED FOR THE DETERMINATION OF ANALYZES OF THE DEMOCRATIC AREA FROM HUMAN SAMPLES, THESE REAGENTS ARE USED WITH ADVACENTAUR, ADVIA CENTAUR CP, ADVIA CENTAUR XP EQUIPMENT.
  • Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC || Importer: SIEMENS S.A

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS INC || Importer: SIEMENS S.A
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA