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 field data for alinity i free t4 result reagent lot: 56159ud00.The ticket search determined that the reagent lot shows higher complaint activity than expected for this product.A review of tracking and trending data did not identify any related trends for the product for the issue.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.A review of the labeling addresses the customer¿s issue.Per the limitations of the procedure section of the package insert, results should be used in conjunction with other data, e.G., symptoms, results of other thyroid tests, clinical impressions, etc.If the free t4 results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.A manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Based on the investigation no product deficiency was identified for the alinity i free t4 result reagent lot: 56159ud00.
|