Events

Alerta De Seguridad para NucliSENS® Lysis Buffer

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 INC. || Imported by: BIOMERIEUX COLOMBIA LTDA..

¿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-020317.
  • Número del evento
    INVIMA 2009RD-0001366
  • Fecha
    2017-03-21
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=96
  • 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 health agency informs that biomérieux, has confirmed other research that the eluate of the product referenced in the previous table, is colored due to the presence of the group hemode the hemoglobin present in samples of whole blood, including spot of dried blood. the presence of hemoglobin causes the inhibition of pcr, leading in most cases to non-interpretable results as it also inhibits internal control, invalidating the test, thus creating a potential risk related to possible false negative or delayed results. it has been confirmed that the root cause of the event is linked to the ph, which for lot 16092902, is 6.9 instead of 7.1 +/- 0.1, according to the product specification.

Device

NucliSENS® Lysis Buffer

Manufacturer

BIOMERIEUX INC. || Imported by: BIOMERIEUX COLOMBIA LTDA.