A suspected false negative for HLA class I with FL1-30 lot 022. Complaint investigation testing was performed using 4 samples with low levels of A2 antibody specificities and 1 sample with low levels of A31 antibody specificities. Investigation confirmed a lower percentage of positive reactions for samples tested with FL1-30 lot 022. In addition, investigation noted that lot specific user document, TDX-OLI-DMR-LOT-8536 revision 01, has incorrect reference values for the distribution of certain HLA class I antigen specificities. Recall start date: May 29, 2024
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