The Health Board is recalling the HYGISUN rapid COVID-19 tests because the test kit has not been subjected to a proper conformity assessment and its distribution is therefore prohibited.
Distributors and medical personnel must immediately discontinue the use of the test kits and arrange for their recall and return. Professional users who are in possession of such test kits are not allowed to provide the service with said kit.
Tagne Ratassepp, head of the medical devices department at the Health Board, said that non-conformity is easy to detect because the test kit does not have a CE marking. "The marking can only be affixed by the manufacturer to a device once the requirements valid in the European Union have been met," Ratassepp said.
The official said that the Health Board has informed the importer of the test kits of the non-conformity of the packaging. The importer has confirmed to the Health Board that the companies that have obtained the tests through them have been informed.
The Health Board said that the tests have been available at over 70 pharmacies. The board pointed out that each distributor must make sure that the manufacturer has complied with valid requirements. If the manufacturer has not complied with the requirements, the device must not be distributed.
"These are tests for professional use only, but we know that they are also distributed to the general public," said Ratassepp.
Non-professional users who recognize the packaging and who still have the test unused and in its packaging have the right to return the test to the point of sale and ask for a refund.
The Health Board added that the test can also be found on the EU market with compliant packaging bearing the CE marking on it. Therefore, users must pay particular attention to the marking of the device.
Editor: Kristjan Kallaste