Events

Alerta De Seguridad para CHEMISTRY CALIBRATORS I I

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. || Imported by: 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-041016
  • Número del evento
    INVIMA 2007RD-0000603
  • Fecha
    2016-10-31
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=116
  • 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
    The healthcare agency notifies, that siemens healthcarediagnostics is carrying out a corrective action in the advia® systems, for the calibrators of the lots described in the table above, because the value assigned to the dbil_2 calibrator, provides a positive bias of approximately 41% in samples of patients, comparison with the reference method for direct labilirubin measurement, this error may result in an overestimation of the direct bilirubin concentration. as a consequence, the results of the patient sample and quality control will be shifted downward from proportionally to align with the reference methodology, beginning with the reassignment of calibrator values for lots 680726, 680726a, 680726b, 680726c, and 680726d, in this sense the ranges should be revised and adjusted.

Device

CHEMISTRY CALIBRATORS I I

Manufacturer

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