Customer complaint (b)(4) was received on (b)(6) 2017 for factor viii antibody screen (303283) lot 3004682.The customer reported that a (b)(6) year old male patient had factor viii antibody screen assay results that were negative, and the laboratory's bethesda assay results were positive (2.4 titer).Factor vii antibody screen assay results are also dependent on the progression of antibody formation as well as if/when fviii therapy is administered.The patient's course of therapy was not available from the laboratory.
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