Section d4: catalog # updated from 08d06-29 to 08d06-74.Lot # updated from 07413be00 to 07413be01.This report is being filed on an international product, list number 08d06-74 that has a similar product distributed in the us, list number 08d06-31.No customer returns available.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 inhouse testing review of complaint activity associated with reagent lot 09201be00 identified normal activity.Tracking and trending reports were reviewed and identified no trends associated with the complaint issue.Device history records for the reagent lot were reviewed and did not identify issues.A retained reagent kit of the complaint lot was tested in a sensitivity setup.No false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.Labeling was reviewed and concluded that the issue is adequately addressed.Based on the investigation, there is no systemic issue or deficiency of the architect syphilis tp assay.
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