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 was performed on lot 53725ud02.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 search for similar complaints did identify an increase in complaint activity for lot 53725ud02, however, no related trends were identified regarding commonalities for complaint lot number and issue.Additionally, in-house performance testing was completed which indicates the product is performing as expected.A review of the device history record did not identify any potential non-conformances, non-conformances, or deviations associated with the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency of the architect free t4 reagent lot 53725ud02 was identified.
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