Urgent ban on sales, marketing, and distribution of Testerit.fi/Global Network Oy coronavirus rapid test marketed at consumers
The Finnish Medicines Agency Fimea has prohibited Testerit.fi/Global Network Oy from selling, marketing, and distributing the ‘2019-nCoV IgG/IgM Rapid Test Cassette Single use kit’ coronavirus test on 29 April 2020. The ban is effective immediately, and it will last until 31 August 2020. In addition, Fimea has ordered the operator to take the product off the market and inform their customers about the recall by 10 May 2020. The order has been enforced with a conditional fine of EUR 200,000.
Testerit.fi/Global Network Oy has repackaged tests meant for professional use with instructions that do not correspond with the manufacturer’s original product. The product description on the operator’s website does not clearly state the tests are not intended or suited for home use by consumers, or that they have not been proven to be safe and reliable in the hands of a non-professional. The marketing on the website and the operations of the business both in terms of the COVID-19 test and as a whole are mainly aimed at consumers.
Using professional tests at home leads to unreliable results and public health risks
Using serological COVID-19 tests (tests based on detecting antibodies) intended for professional use in self-administrated testing may lead to misunderstandings on whether or not the patient carries the virus, as well as false assumptions about possible immunity gained. According to various studies, the antibodies reach a detectable level in the patient's blood one to two weeks after the infection, meaning that the test may give a false negative result in the early stage of infection. Serological rapid tests also do not give a reliable indication of the elimination of infection from the body in the final stage of the disease.
When using a test intended for professional use, a non-professional user may make mistakes when administering the test and also interpret the result incorrectly due to a lack of scientific knowledge. The unreliability of the test and the ambiguity of the results pose a health risk to the user of the test and their immediate surroundings, as well as a considerable risk to public health in the form of an increase in the spread of infections.
Decision on ban is part of market surveillance
Fimea has issued the ban in accordance with the Medical Devices Act 629/2010 (46 §, subsections 2 and 3) as part of its market surveillance duties related to medical devices.
- Johanna Ekholm, Senior Engineer, tel. 0295223272
- Nelli Karhu, Senior Inspector, tel. 0295223276
- Johanna Nystedt, Director, Supervision of pharmaceutical operators, tel. 0295223210