New Tool: ProSource
Checkout our packaging and processing solutions finder, ProSource.
Start Your Search

FDA Gives LuSys Labs Class I Recall for COVID Tests

LuSys Laboratories didn’t submit their tests for FDA authorization before they began distributing to consumers.

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. 

Test Your Supply Chain Smarts
Take Healthcare Packaging's supply chain quiz to prove your knowledge!
Take Quiz
Test Your Supply Chain Smarts
Discover Our Content Hub
Access Healthcare Packaging's free educational content library!
Unlock Learning Here
Discover Our Content Hub