Events

Alerta De Seguridad para Cobas EGRF Mutation Test and Cobas cfDNA Sample Preparation Kit

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 ROCHE MOLECULAR SYSTEMS || Importer: PRODUCTOS ROCHE 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-030416
  • Número del evento
    INVIMA 2015RD-0003495
  • Fecha
    2016-04-13
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=147
  • 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
    During internal studies using artificial plasma, several mutations (l858r, deletions of exon 19, t790m) generate inconsistently the result "mutation not detected" (which could be considered as false negative) with the kitcobas® egfr mutation test, v2 when used in set with the cobas® cfdna sample preparation kit. the internal research carried out by our parent company suggests that the combination of the glass fiber mesh of the column with the substances of the wash buffer reagent are the primary responsible for the observed inhibition.

Device

Cobas EGRF Mutation Test and Cobas cfDNA Sample Preparation Kit
  • Modelo / Serial
    Cobas EGRF Mutation Test: reference: 07248563190, all || lots. || Cobas cfDNA Sample Preparation Kit: reference: 07247737190, || all lots.
  • Descripción del producto
    DETERMINATION OF DIFFERENT ANALYTICS RELATED TO SAMPLES FROM THE HUMAN ORGANIZATION
  • Manufacturer
    ROCHE MOLECULAR SYSTEMS || Importer: PRODUCTOS ROCHE S.A

Manufacturer

ROCHE MOLECULAR SYSTEMS || Importer: PRODUCTOS ROCHE S.A