The Finnish Medicines Agency Fimea has ordered the immediate recall of a novel coronavirus quick test which was erroneously marketed to consumers, according to the agency in a statement published Thursday.
Fimea said the test, named “2019-nCoVIgG/IgM Rapid Test Cassette Single use kit” should immediately be pulled from the market. The agency issued the order on Wednesday.
The tests have been on sale on the website testerit.fi, which is owned by the firm Global Network, according to the regulator. Global Network is registered in Turku and its website sells various kits the firm claims can check for pregnancy, drugs and DNA in people, and also offers other kits it says can analyse indoor air quality as well as water purity.
The agency said the sales ban was in place until 31 August and ordered the company to inform customers who bought the product by 10 May, under threat of a 200,000 euro fine if it does not comply with the orders.
Tests intended for professional use were repackaged with user instructions that do not match the actual product being sold, according to the agency. The description of the product on the firm’s website also did not clearly indicate that the tests were not intended for household use by regular consumers, the agency said in a statement.
Fimea said the company was chiefly marketing the coronavirus tests to regular consumers but also its other products.
The regulator said that normal consumers using serological (antibody) tests intended for professional use can lead to unreliable results as well as pose risks to public health, noting that there is a risk that individuals using the kits at home could potentially carry out the tests, or interpret their results incorrectly.
Fimea noted that quick serological tests do not reliably indicate that a virus has left a person’s body.
It said a person could incorrectly evaluate his or her health status and draw the wrong conclusions about things like possible immunity to the disease.
Both the unreliability and ambiguity associated with testing at home poses a health risk to both consumers as well as the communities in which they live. Additionally, Fimea said there was a significant risk to public health as incorrect test results increase the risk of the spread of the infection.