Events

Alerta De Seguridad para laboratory analyzer Vidas 3

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 Biomerieux S.A. || Biomerieux Italia Spa.

¿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
    I1411-475
  • Número del evento
    2014DM-0011236
  • Fecha
    2014-11-21
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=192
  • 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 manufacturer states that the previous software versions may present clearly identified anomalies related to equipment calibration, negative results for cmvu and cmva tests, as well as false negatives produced by the stability of the urea buffer in cmvu tests, leading to potentially being presented adverse events on the patient due to altered analytical test results.

Device

laboratory analyzer Vidas 3
  • Modelo / Serial
  • Descripción del producto
    The autonomous VIDAS® 3 immunodiagnostic system is an automated multiparameter analyzer for random access chemo-fluorescence immunoassay (ELFA) tests. It uses urine, serum or plasma samples and fluids for in-vitro diagnostic tests in the areas of deserology, immunology, chemistry, microbiology and coagulation. It is an automated system that reports the values of the tests and communicates the results of the patient's clinics.
  • Manufacturer
    Biomerieux S.A. || Biomerieux Italia Spa

Manufacturer

Biomerieux S.A. || Biomerieux Italia Spa