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.
The recall notice issued by the FDA notes, “there is a risk of a potential false negative, false positive, and misinterpretation of results from these tests.” The recall affects 164,250 tests that were distributed in the United States between June 2020 and July 2021. LuSys also sold their tests in Canada, China and Mexico under various names including Luscient Diagnostics, Vivera Pharmaceuticals and EagleDx.