Events

Alerta De Seguridad para LCx kit Neisseria Gonorrhoeae. Lot: 84075M400

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbott Laboratórios do Brasil 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
    710
  • Fecha
    2002-07-25
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    Abbott Laboratories of Brazil Ltda., Is working to accelerate the replacement of the LCx Neisseria Gonorrhoeae product. Lot: 84075M400. and recommends alternative methods for performing the test.///////NOTE: Clinical studies described in the Technical Manual of the trial, represent a small percentage of patient samples that are close to the test cutoff (<0.80). Based on this data, review of patient outcomes is not recommended because the risk of a low positive test being reported as negative is minimal. Thus with any diagnostic test, the results of the LCx Neisseria Gonorrhoeae kit. Batch: 84075M400 should be interpreted in conjunction with other clinical and laboratory data.
  • Causa
    Studies conducted by abbott laboratories have demonstrated that the analytical sensitivity may be out of the one specified in the package insert as being 10 colony forming units. these studies were based on a panel with sensitivity close to the assay cutoff (<0.80) and may generate a positive-low as negative.
  • Acción
    Discontinue use of the LCx Neisseria Gonorrhoeae kit. Lot: 84075M400

Device

LCx kit Neisseria Gonorrhoeae. Lot: 84075M400

Manufacturer

Abbott Laboratórios do Brasil Ltda.
  • Source
    ANVSANVISA