An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 8d06-74 that has a similar product distributed in the us, list number 8d06-31.
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The complaint investigation for the architect syphilis tp assay lot 11052be01 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 of retained kits with the complaint lot number.Return testing was not completed as returns were not available.Trending review determined no trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Inhouse testing determined that the sensitivity performance is not negatively impacted.Labeling was reviewed and adequately addresses the customer issue.Based on our investigation, no systemic issue or deficiency with the architect syphilis tp reagent lot 11052be01 was identified.
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