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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.

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FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
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FDA warning letters surge - is your team prepared?