fox43

Another at-home COVID test is being recalled

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 ...
MassLive

At-home COVID tests recalled by SD Biosensor after determining the non-FDA-approved tests were illegally imported

SD Biosensor, Inc., a South Korean diagnostic company and COVID-19 test maker, recently recalled at-home tests that made their way to the U.S. illegally and never received a stamp of approval from the ...
FierceBiotech

Roche, SD Biosensor recall 500,000 at-home COVID tests due to bacteria risks

If you’re still taking home COVID-19 tests, the FDA wants you to double-check the packaging. The agency is warning users of contaminated ingredients in certain packages from SD Biosensor, and ...
Business Wire

SD BIOSENSOR Issues Notification of Voluntary Recall of Non-EUA Authorized ‘STANDARD Q COVID-19 Ag Home Test’ in the United States

SUWON, South Korea--(BUSINESS WIRE)--SD Biosensor, Inc., a global in-vitro diagnostics company, is voluntarily recalling its STANDARD Q COVID-19 Ag Home Test in the United States, due to confirmed ...