483
Kentucky Blood Center IncKentucky Blood Center Inc – FDA 483, Sep 18, 2023
Record Details
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.
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ID · 5852aaf7-e268-4842-931e-afdfcb888bd6
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