The complaint investigation for falsely elevated architect free t4 results 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.Review of all the information provided by the customer was reviewed.Return testing was not performed as returns were not available.The ticket search by lot indicates that the reagent lot shows elevated complaint activity; however, no trends were identified.Device history record review did not show any nonconformances, potential nonconformances or deviations associated with the likely cause list number and complaint issue.In house testing of retained likely cause lot met acceptance criteria and the product is performing as expected.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the architect free t4 for lot number 56026ud00 was identified.All available patient information was included.Additional patient details are not available.
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