The complaint investigation included review of data and information provided by the customer, search for similar complaints, ticket and trending review, labeling review, device history review, and inhouse testing of retained reagent lot 43520fn00.Return testing was not completed as returns were not available.Data and information provided by the customer was reviewed and support the complaint issue without indication for any additional issue.The lot search review did not identify an increase in complaint activity for the issue of false reactive results.The ticket and trending review for the complaint list number did not identify any trends.Device history review in did not identify any non conformances or deviations associated with complaint lots and the customer¿s issue.Performance testing was performed using an in-house retained kit of complaint lots.Acceptance criteria was met indicating the lots are performing as expected.A review of the labeling adequately addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency with the alinity i hbsag qualitative ii reagent, lot 43520fn00 was identified.
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