In 2018, the CDC investigated the reports of several patients in multiple states who developed bacterial infections after receiving the ReGen Series stem cell products distributed by Liveyon, LLC. The CDC determined the infections were probably due to contaminated stem cell products after they found bacteria in a number of unopened vials obtained from multiple clinics. The ReGen Series products were subsequently recalled by Liveyon, LLC. As part of the investigation, the FDA inspected Genetech, the company that processed these products and found deviations in good manufacturing processes (GMPs) and safety concerns with donor screening and eligibility.
