Review of complaint activity determined there was normal complaint activity for the prism htlv-i/htlv-ii reagent, lot 94091li00.Tracking and trending report review determined there are no related adverse or non- statistical trends.The performance of the likely cause lot was investigated, and no issues were identified.Using customer field data, the initial reactive rate (irr), repeat reactive rate (rrr), and specificity for lot 94091li00 were evaluated.The irr, rrr, and specificity were all determined to be within package insert specifications.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency was identified for the prism htlv-i/htlv-ii reagent, lot 94091li00.
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