The kits were being offered by the Finnish website testerit.fi, with a price tag of €200 each. The company had repackaged testing kits that were intended for use by medical professionals, and selling them for use at home instead.
Fimea says the operating instructions in the testing kid did not correspond to the product originally placed on the market by the manufactuer, and that the Testerit website did not make it clear the tests aren’t suitable for consumers at home.
The tests, say Fimea, “have not been shown to be safe and reliable in the hands of a lay person.”
The test involves pricking the finger to take a small amount of blood and putting it on a testing kit which indicates positive or negative.
The ban was handed down as part of Fimea’s monitoring programme, which looks at healthcare equipment and supplies available in Finland.
Testerit has been told to withdraw the home testing kit from its website, and by Thursday afternoon it was no longer possible to buy one.