Events

Alerta De Seguridad para Quantiferon-TB Gold

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 QIAGEN || Importer: QUIMIOLAB 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
    RRD-030316
  • Número del evento
    INVIMA 2012RD-0002301
  • Fecha
    2016-03-07
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=153
  • 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
    Voluntary withdrawal of the blood collection tubesquantiferon-tb gold tb-antigen, identified with lota150135a, which are part of the kits previously referred. during the manufacture of these tubes, a quantity of endotoxin that did not meet the quality specifications was discarded and the remaining portion, after being subjected to additional tests, was partially released. lacasa parent company qiagen has changed the deliberation procedures of said tubes and has identified that the lot a150135a that was partially released has not yet expired. to date there has been no evidence that the performance of the product is affected for this lot, however, no the possibility of a high positivity due to the increase in endotoxin may be ruled out.

Device

Quantiferon-TB Gold
  • Modelo / Serial
    Lot of tubes: A150135A || R eference: 0590-0201; Lot: 059061291 || Reference: 0597-0201; Lot: 059772271 || Reference: 0597-0701; Lot: 059772281
  • Descripción del producto
    INDIRECT TEST FOR THE DETECTION OF M. TUBERCULOSIS INFECTION
  • Manufacturer
    QIAGEN || Importer: QUIMIOLAB LTDA

Manufacturer

QIAGEN || Importer: QUIMIOLAB LTDA
  • Empresa matriz del fabricante (2017)
    QIAGEN N.V.
  • Source
    NIDFSINVIMA