On February 11, the Antimonopoly Committee of Ukraine issued mandatory recommendations to the limited liability companies Medfix and Incos Line, which distribute rapid tests for the diagnosis of Covid-19, to stop distributing information on the packaging of media about the possibility of self-use of tests by citizens.
The reason for the statement of violation to the Committee was the use on the packaging of test systems of the inscriptions “FOR SELF-CONTROL” and “For personal use”. According to the results of the research conducted by the Committee, it was established that such inscriptions did not comply with the requirements of Ukrainian legislation. After all, according to the current Technical Regulations for in-vitro medical devices, a product for self-monitoring is a medical device intended by the manufacturer for independent use at home.
However, the Committee found that the main component of the test, made in the United States, is intended for professional use only and contains the labels “Single test” and “For professional use only”. This is evidenced by the information posted by the manufacturer of rapid tests on the packaging of drugs, in the instructions, and on the manufacturer’s website.
That is why these designations may give consumers the impression that Ukrainians can use tests on their own at home, although they are intended for professional use. After all, the correctness of the test at home and the interpretation of its results is solely at the risk and risk of the consumer. In view of this, the Committee concluded that the actions of these companies contained signs of violation of the Law of Ukraine “On Protection against Unfair Competition” in the form of dissemination of information that misleads consumers, and recommended that the violation be stopped.