The customer observed falsely elevated alinity i free t4 result for one patient.The customer repeated the sample and normal result was obtained.The following data was provided: customer¿s reference range: 0.7 to 1.48 ng/dl on (b)(6), 2024 sid (b)(6), initial result = >5.0 ng/l; repeat result = 0.96 ng/l there was no impact to patient management reported.
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The complaint investigation for falsely elevated alinity i free t4 results included a review of data and information provided by the customer, ticket trending review, device history record review, and labeling review.In addition, in-house testing of retained reagent kit was also completed.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 identify an increase in complaints for lot 56159ud00, however, in-house performance testing was completed which indicates the product is performing as expected.A review of the device history record did not identify any non-conformances or deviations with lot number 56159ud00 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency was identified with the alinity i free t4 reagent, lot number 56159ud00.
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