Fresenius Se – FDA Warning Letter, Jan 28, 2011

The FDA issued a Warning Letter to Fresenius SE regarding the marketing of their Red Blood Cell (RBC) Set and the AS104 Blood Cell Separator in the U.S. without proper marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

The AS104 Blood Cell Separator was cleared in 1990 (K895435) solely for therapeutic plasma exchange (TPE), with specific bloodlines (PL-1 tubing set) for that purpose. Labeling claims for therapeutic RBC exchange were not cleared for the AS104 system, nor were the tubing sets necessary for RBC exchange treatments. Similarly, the Com.Tec system (K060734), cleared in 2006, was also solely for TPE.

Despite the AS104 no longer being manufactured, Fresenius continues to service and repair it in the U.S. The FDA learned that Fresenius is marketing the RBC Set (Catalog Number 9007601) for depletion or exchange of red blood cells during therapeutic apheresis procedures on the AS104, specifically for sickle cell disease patients.

This marketing of the RBC Set, and the AS104 when promoted for RBC exchange, renders them adulterated under Section 501(f)(1)(B) of the Act, as there are no approved premarket approval (PMA)