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, and field data 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.Device history review did not identify any potential non-conformances, non-conformances, or deviations with the complaint lot.Ticket search by lot did not identify an increase in complaint activity for the complaint issue.The ticket trending review did not identify any trends.The overall performance of the alinity s hbsag reagent was reviewed using field data from customers.A review of field data for the overall performance of lot 46338fn00 indicated the product was performing within product requirements.Labeling was reviewed and was found to address the customer reported issue.Based on the results of the investigation, alinity s hbsag reagent, lot number 46338fn00 met performance requirements and no systemic issue or product deficiency was identified.
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