The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.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 ticket search by lot indicates that the reagent lot 64248uq04 performs as expected for the product.The ticket trending review did not identify any related trends for the product for the complaint issue.A review of the device history record did not identify any non-conformances or deviations associated with the reagent lot and 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 carbon dioxide reagent lot 64248uq04 was identified.
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