Events

Safety Alert for Home Aware Home-use HIV and STD Test Kits

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by CuraHerbDistributor / Home Aware.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-09-11
  • Event Date Posted
    2012-09-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120911a.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    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

Home Aware Home-use HIV and STD Test Kits

Manufacturer

CuraHerbDistributor / Home Aware
  • Source
    DH