Update to sections d4 - expiration date, d4 - primary udi number, and h4 - device mfg date
the complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in-house testing of a retained reagent kit.Return testing was not completed, as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.The ticket search by lot identified elevated complaint activity; however, no trends regarding commonalities for complaint lot number and issue were identified.Device history record review did not identify any non-conformances, potential non-conformances, or deviations for the likely cause list number and complaint issue.Retained analysis of architect free t4 of the complaint lot was performed.All specifications were met, indicating that the lot generates the expected results and is performing acceptably.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect free t4, lot 56026ud00, was identified.
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