Dive Brief:

• Roche partner SD Biosensor is recalling illegally imported rapid antigen COVID-19 tests from the U.S. and investigating how the products entered the country.
• In a notice to disclose the recall, FDA said there are "confirmed reports" of illegal importation of the Standard Q COVID-19 Ag Home Test and South Korea's SD Biosensor is looking into which distributors or people were involved. There is no evidence of distribution directly to consumers.
• FDA released details of the recall as part of a flurry of notices about rapid COVID-19 tests, which also saw it warn the public about unauthorized tests from E25Bio and Empowered Diagnostics.

Dive Insight:

Roche formed a global distribution agreement with South Korea's SD Biosensor, leading to a series of launches, including the recent introduction of a rapid COVID-19 test to the U.S. market. It has now emerged that SD Biosensor tests entered the U.S. via an illegal backdoor.

FDA said it is unlikely that consumers will encounter the illegally imported tests. However, SD Biosensor is issuing a voluntary recall "out of an abundance of caution." If a consumer does have one of the tests, the agency is encouraging them to discard the kits as they have not been authorized, cleared or approved for use in the U.S. FDA is "strongly" encouraging people who have used the kits to consider retesting.

SD Biosensor is now working to stop more tests from illegally entering the country. The company is looking into how the products entered the U.S. and will order the distributors or people involved to immediately stop the illegal activity and recall any products that are already on the market. SD Biosensor is also strengthening its contracts, and their enforcement, to stop further attempts at illegal imports. Any people or companies caught illegally importing tests in the future "will face strict legal action and liabilities for damages." 

FDA disclosed the SD Biosensor recall on the same day as it published a warning against the use of the E25Bio COVID-19 Direct Antigen Rapid Test. The agency has not authorized, cleared or approved the test, which may include false labeling, and "is concerned about the risk of false results" because E25Bio has not adequately demonstrated the accuracy of the product.

The test was sold directly to consumers, raising concerns at FDA that people may injure themselves when self-collecting samples from the throat. FDA wants consumers and healthcare professionals to report any suspected false results or injuries. The agency has yet to receive any reports of injuries or adverse health consequences associated with the test.

Late last month, FDA issued another notice about unauthorized COVID-19 tests. Empowered Diagnostics is recalling more than 280,000 antigen tests and more than 2,100 antibody tests. According to FDA, the products shipped with incorrect labeling indicating they are authorized by the agency.

FDA has not received any reports of adverse health consequences or deaths but, given the potential for false results, has categorized the recall as a Class I event. The agency said "organizers of large testing programs, such as in the workplace or schools" may be using the unauthorized tests.