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 ...
The Drugs Controller General of India (DCGI) has directed all state licensing authorities (SLAs) to recall batches of rapid antigen in vitro diagnostic (IVD) kits of Gujarat-based manufacturer Labcare ...
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 ...