Safety Warning — iCare / JAL Medical Self-Tests (Not CE-Marked)

Name: How to Use INSTI HIV Self Test
Uploaded: 2019-03-31T08:00:00+08:00
Duration: 4 min 35 s
Description: INSTI was developed as a simple and uncomplicated home HIV test. Follow the video below or read the step-by-step guide to learn how to use the test and get the results.

This warning applies to the following products manufactured by JAL Medical (Singapore) Pte. Ltd. and supplied by One Self B.V.:

iCare HIV Self Test
iCare Syphilis Test
iCare Hepatitis B (HBsAg) Test
iCare Hepatitis C (HCV) Test
Other iCare tests from JAL Medical

These products do not have a valid CE marking for use within the European Economic Area. As a result, their safety, performance, and reliability have not been assessed in accordance with European IVDR regulations.

Users may therefore be at risk of:

False-negative results
False-positive results
Insufficiently validated test performance

What should you do?

Do not use the tests listed above.
Have you already used one of these tests? Please retest using a CE-marked test or contact your healthcare provider.