FDA 483 - Kentucky Blood Center Inc - September 18, 2023

Kentucky Blood Center Inc, a blood bank in Lexington, KY, was cited for an unacceptable method for requalifying deferred donors. The firm re-entered a donor who was previously HCV repeat reactive using only one anti-HCV screening test, contrary to FDA's requirement for two different, licensed tests. This lapse resulted in the distribution of red cell and plasma units from this improperly re-entered donor.