WASHINGTON — An at-home COVID-19 testing kit is being recalled for failing to meet FDA requirements. The lack of FDA approval means that there is not sufficient data demonstrating that the test's ...

This story is part of Forbes’ coverage of Korea’s Richest 2023. See the full list here. With dwindling demand for Covid-19 testing kits, Cho Young-sik, founder of SD Biosensor, is refocusing on new ...

SD Biosensor has launched a recall for the affected Pilot tests, and the FDA said it is working with Roche to determine how many have been sold to customers. (Circle Creative Studio/iStock/Getty ...

More than a half million home COVID-19 tests from Roche and SD Biosensor should be thrown out immediately, the Food and Drug Administration is warning, citing "significant concerns" over bacteria that ...

All three testmakers cited in March 1 FDA warning letters have received the agency’s clearance to market COVID-19 diagnostics separate from those identified in the letters, including an at-home test ...

(RTTNews) - Seoul, South Korea -based SD Biosensor, Inc. has recalled specific Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics in the United States, citing potential microbial ...