Events

Alerta De Seguridad para Film Array Blood Culture Identification BCID Panel

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 BIOFIRE DIAGNOSTICS LLC || Importer: BIOMERIEUX COLOMBIA S.A.S..

¿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-030516
  • Número del evento
    INVIMA 2014RD-0003003
  • Fecha
    2016-05-03
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=143
  • 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
    Labeling problem with a suitable electronic code key, generating the download of an obsolete version of the instructions of the product by the customers. the obsolete use instructions refer to the old syringe loading system, in contrast to the current system, which is based on an injectable method of the vial. the most significant difference between the two sets of instructions is the volume of the sample needed to perform the test. the syringe system requires 100 ul of the sample, while the new system requires 200 ul demonstrates. biofire has shown that there are no differences between the two sample volumes, therefore, any risk to patients and the risk of erroneous results are very low.

Device

Film Array Blood Culture Identification BCID Panel
  • Modelo / Serial
    Code: RFIT-ASY-0126, lots 440415, 442715, 447415, 447615, || 448315, 454115, 458915, 459615, 462615, 470515, 400216, || 400716, 403016, 403616, 405416, 407016, 407416, 410216, || 412516. || Code: RFIT-ASY-0127, lots: 438115, 449515, 442815, 459715, || 463115, 468015, 410016
  • Descripción del producto
    DETERMINATION OF DIFFERENT ANALYTICS RELATED TO SAMPLES FROM THE HUMAN ORGANIZATION
  • Manufacturer
    BIOFIRE DIAGNOSTICS LLC || Importer: BIOMERIEUX COLOMBIA S.A.S.

Manufacturer

BIOFIRE DIAGNOSTICS LLC || Importer: BIOMERIEUX COLOMBIA S.A.S.