Further investigation of the customer issue included a review of the complaint text, in-house testing, a device history review, a search for similar complaints, and a review of labeling.Return material was not available from the customer.A specificity testing protocol was executed; testing met the acceptance criteria and determined the reagent is performing acceptably.No systemic issue was identified which would indicate a product deficiency from the device history review.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the architect havab igg reagent list number 06c29, lot numbers 74119li00, was identified.
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