FDA Gives LuSys Labs Class I Recall for COVID Tests

Two months ago, the FDA issued a safety warning against using LuSys Laboratories’ unauthorized antigen and antibody tests. According to a recent FierceBiotech article, the tests are now the target of a Class I recall. The recall applies to both saliva and nasal antigen tests, and their blood antibody test. Not only were none of the tests authorized, the company didn’t bother to submit applications for authorization before they started distributing.