Labeling of Red Blood Cell Units with Historical Antigen Typing Results

The information collection provisions found in the guidance include FDA recommendations for including the non-ABO/Rh(D) historical antigen typing results on a tie-tag or directly on the container label, and for conveying any change in their antigen typing or labeling practices to their consignees, including practices for repeating historical RBC typing results on current donations and for labeling RBC units with historical RBC antigen typing results.

The latest form for Labeling of Red Blood Cell Units with Historical Antigen Typing Results expires 2021-11-30 and is listed under ICR 201810-0910-010.