The complaint investigation for falsely elevated alinity i free t4 result included a review of data and information provided by the customer, ticket trending review, device history record review, and labeling review.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A review of the complaint trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with lot number 53312ud00 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.Per product labeling, to ensure consistency in results, recentrifuge specimens prior to testing if they contain fibrin, red blood cells, or other particulate matter.Reagent handling and storage instructions are provided in the package insert, including precautions to minimize the risk of contamination and the potential to compromise reagent performance.Additionally, 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.Based on this investigation, no systemic issue or deficiency was identified with the alinity i free t4 reagent, lot number 53312ud00.
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