The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.Additionally, in-house testing was performed.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.An increase in complaints has been observed for lot 56159ud00, however, in-house performance testing was completed which indicates the product is performing as expected.The device history record review did not identify any nonconformances, potential nonconformances or deviations associated with lot number 56159ud00 and the complaint issue.Labeling was reviewed and adequately addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity i free t4 for lot 56159ud00 was identified.
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