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 using lot 62078m500 and met acceptance criteria and determined the reagent is performing acceptably.The device history review did not identify any non-conformances or deviations related to the customer's observations.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 prism chagas reagent, list number 07k35-68, lot number 62078m500, was identified.
|