Alerta De Seguridad para Accu-HIV 1 & 2 Saliva Test

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

¿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
  • País del evento
  • Fuente del evento
  • 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
    Press release
  • Causa
    Alert over an hiv home test kit today, the department of health (dh) advises members of the public who possess a hiv home test kit called "“accu-hiv 1 & 2 saliva test” to stop using it immediately as no known competent authority has recognised its safety and effectiveness as a diagnostic medical device. dh tenders the above advice after assessing a health canada medical device safety alert which the department's surveillance scheme detected.   "though dh has not received any related adverse case notification nor has the product been found on sale here, because of the popularity of internet trading - a major channel for sale of the said product, dh considers it prudent to inform our public of its assessment," a dh spokesman explains. the spokesman states that in fact, the world health organization recommends further research in the area before formulating definitive guidance on whether to promote or discourage self-testing.   "members of the public in need can call the dh's aids hotline on 2780 2211 for a free, anonymous and confidential hiv test.  alternatively, they may attend our social hygiene clinics or methadone clinics (for heroin drug users); or approach individual non-governmental organisations; or consult their own family doctors for hiv testing," the spokesman advises. "nowadays, there is growing public health concern as more and more consumers are purchasing all sorts of medical test kits through all possible channels, the internet being an increasingly important one, for use in their homes to screen, diagnose or monitor a range of health conditions.  kits so marketed are usually considered as medical devices and may therefore provide as much potential benefits as risks," the spokesman gives his background remarks.   the spokesman elaborates that while there could be possible benefits like convenience, privacy and pricing, if devices are not bought from trustworthy sources, any of the following could happen - a) they may not be of acceptable safety, effectiveness or quality; b) they may have wrong labels and/or package inserts; c) they might have been been distributed or stored improperly, thus tempering their safety, effectiveness or quality; and /or d) they may even be counterfeit pieces. "the above situations could then present the following risks to user's health - a) not getting the medical treatment that is needed;   b) change treatment regime or lifestyle based on faulty results; c) get incorrect diagnosis that causes needless worry, plus perhaps medical testing that is not only unnecessary, but may even present a risk of side effects; and d) can cause direct harm to health," the spokesman illustrates. "therefore, it is of utmost importance to realise that do-it-yourself medical tests are not a replacement for professional healthcare and they can never be.  medical kits for self-testing are best used when they are part of a comprehensive programme that is supervised by a healthcare professional," the spokesman emphasizes.   "to minimise your risk, consumers should -   a) always buy their test kits from reliable sources; b) read and follow the directions for storage.  otherwise, it could affect the accuracy of the test results; and c) check to see if there are expiry dates. before using the kits, consumers should - a) read the labels and directions carefully.  be sure you understand exactly what you are supposed to do and follow the directions exactly as described; b) become familiar with the limitations of the tests.  be aware of what alarms and error messages mean.  make sure you know what to do if the devices fail. after conducting the test, consumers should - a) remember that tests may not be 100% accurate.  test results should always be evaluated in the context of your overall health and in consultation with qualified health care professionals; b) do not take any action or make drastic changes to your treatment without first consulting your healthcare professionals; c) see your healthcare attendants if you are feeling sick or worried, or if the test instructions recommend it; and d) report any problems with kits to the trade or dh.  our medical device control office does follow up on reported problems and your calls can help ensure that medical devices available here are safe, effective and of quality," the spokesman concludes. ends.


  • Modelo / Serial
  • Descripción del producto
    Press release: Alert over an HIV home test kit
  • Manufacturer


  • Source