Events

Alerta De Seguridad para REAGENTS R-GENE

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. || 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-060516
  • Número del evento
    INVIMA 2013RD-0002673 ; INVIMA 2013RD-0002694 ; INVIMA 2014RD-0002819 ; INVIMA 2016RD-0003529
  • 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
    The use of these references in the rotorgene system is validated during the test using the consumable called "strips 4 tubes", however, the association between this consumable with the argene reagents has not been specified in the inserts of the referenced reagents. an internal study has confirmed that the interaction between other available rotorgene consumables can cause validation problems in control and / or internal control samples, demonstrating out-of-range results or illegible and nosigmoid curves as expected. for these reagents, there is a potential risk of causing delays in the results taking into account the incompatibility between the reagents and the consumables. for hsv2 reagents, the sensitivity of the test is reduced causing low positive results that can be interpreted as false negative results.

Device

REAGENTS R-GENE

Manufacturer

BIOMERIEUX S.A. || Importer: BIOMERIEUX COLOMBIA S.A.S