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, and retained product analysis.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of tracking and trending did identify trends for list number 07p70, however, an increase in complaint activity for lot 53312ud00 was not identified.Additionally, in-house performance testing was completed which indicates the product is performing as expected.Device history record review did not identify any non-conformances or deviations with the complaint lot number and issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency with the alinity i free t4 reagent lot 53312ud00 was identified.
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