Alerta De Seguridad para Home Aware Home-use HIV and STD Test Kits

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por CuraHerbDistributor / Home Aware.

¿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
  • Fecha
    2012-09-11
  • Fecha de publicación del evento
    2012-09-11
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: home aware home-use hiv and std test kits the health canada has issued a safety advisory regarding online selling of unlicensed home-use hiv and std test kits for use with urine, saliva and blood samples on the website curaherbdistributor (curaherbdistributor.Com). according to the health canada, curaherbdistributor's hiv kits carry the "home aware" brand and have not been evaluated by health canada for safety and effectiveness. in addition, curaherbdistributor is also attempting to sell online a number of other test kits under the "home aware" brand. health canada has not licensed "home aware" tests kits for any of the following conditions indicated on the website, namely syphilis, trichomonas vaginalis, gonorrhea, chlamydia, hepatitis (b/c) or herpes simplex. health canada advised consumers to consult their healthcare practitioners if they have used any home-use test kits sold via the curaherbdistributor.Com website or under the "home aware" brand and are concerned about their health. for further details, please refer to the health canada website: http://www.Hc-sc.Gc.Ca/ahc-asc/media/advisories-avis/_2012 /2012_137-eng.Php posted on 11 september 2012.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Home Aware Home-use HIV and STD Test Kits
  • Manufacturer

Manufacturer