If all units are observed with the suggested enhanced visual inspection, and affected units removed, is leukoreduction necessary for units for which no suspect particulates are observed?
No. Although leukoreduction provides known benefits to selected blood recipients and many believe that it provides additional, more general, benefits, FDA does not currently require leukoreduction of all units. If units are not normally leukoreduced and particulates are not observed, we do not believe that the units pose an increased risk.
