Reputable British companies and brands like SELFCHECK spend tens of thousands of pounds every year to ensure that the tests you receive are fully compliant with UK medical device regulations.
This means extra costs for additional independent evaluations of our tests by scientists and doctors to ensure that the tests are reliable, safe and easy to use by the general public, as well as for regular independent on-site audits of our UK manufacturing facility and research labs.
But it is still far too easy to buy self-test kits online that do not meet the strict medical device standards in the UK. Such companies blatantly ignore the regulations, often making false claims about MHRA or NHS 'approvals' - putting profit above public safety.
Three quick checks to see if you have been scammed
- Check that the test kit you have has a CE logo (or UKCA logo) with a number next to it on the packaging. This means that the test has been certified for self-testing in the UK. If the test has a CE or UKCA mark without a number next to it, this means that the test is for professional use by doctors and other healthcare professionals in a medical setting only. The instructions may be confusing, with scientific jargon instead of written in plain English for ordinary people. For example, who would know what "transfer 80µL of finger-stick whole blood" means?!
- If the packaging or advertising only says FDA approved then this is irrelevant as it only applies to products sold in the USA.
- If you have purchased a self-testing kit, and the instruction leaflet says that the test is for professional use only, then the product should not be sold to the general public. Because the tests have not been through the rigorous approval system for self-testing kits in the UK, these tests may be priced cheaply online but, like most things in life, you get what you pay for.
What to do if you have purchased a fake self-testing kit
If you have purchased a self-testing kit that doesn’t have a CE or UKCA mark on the box with a number next to it, or if the instruction leaflet says ‘for professional use’ then contact your local trading standards office.
Let’s make self-testing safer and better for everyone.
About SELFCHECK self-tests
SELFCHECK self-test kits are assembled in the UK by a biotech company that specialises in the design and development of new medical diagnostics for use by hospitals and doctors. Our scientists and self-test experts provide SELFCHECK customers with professional help and advice to use our tests.
For further information visit selfcheckmedical.com