The complaint evaluation 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 in-house testing of alinity i anti-hcv reagent lot 40373be01.The evaluation of complaint data for the product and likely cause alinity i anti-hcv reagent lot 40373be01 identified as expected.Trending review determined no adverse trend for the issue for the product.The ticket trending review of at least 12 months complaint data for the likely cause list number does not identify any adverse or non-statistical trend.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.In-house testing of a retained reagent kit of lot 40373be01 was performed, showing that the lot generates the expected results and no false non-reactive results were obtained, indicating that the sensitivity performance is not negatively impacted.The clinical sensitivity of the lot was evaluated by testing two commercially available seroconversion panels (zeptometrix hcv 9047 and hiv 9045).The seroconversion panel results were compared to historical architect anti-hcv test results provided by zeptometrix.The lot detected the same bleeds as reactive for the seroconversion panels.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.There was no issue with reagent performance identified.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity i anti-hcv reagent lot number 40373be01.
|