Alerte De Sécurité sur Home Aware Home-use HIV and STD Test Kits

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par CuraHerbDistributor / Home Aware.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2012-09-11
  • Date de publication de l'événement
    2012-09-11
  • Pays de l'événement
  • Source de l'événement
    DH
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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

  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Home Aware Home-use HIV and STD Test Kits
  • Manufacturer

Manufacturer