Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

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.

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.
Read More
FDA warning letters surge - is your team prepared?
Researched List: Blister Machines for Life Sciences
Need a blister machine for life sciences packaging? Our curated list features companies serving pharmaceutical, medical device, nutraceutical, and cosmetic industries. Download to access company names, locations, machine specifications, descriptions, and more.
Download Now
Researched List: Blister Machines for Life Sciences