The customer observed falsely elevated architect free t4 results for one patient.The following data was provided (free t4 reference range 0.07 to 1.48 ng/dl): sid (b)(6) initial free t4 result was 2.05 ng/dl, repeated 1.26 and 1.26 ng/dl, additional results provided: anti-hbs 93.87 miu/ml, anti-hcv 0.09 s/co, ft3 2.58 pg/ml, hbsag 0.00 iu/ml, tsh 1.0730 and 1.0883 uiu/ml, ft3 2.59 pg/ml.No impact to patient management was reported.
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Data and information provided by the customer were reviewed and support the complaint issue.The ticket search by lot indicates that the reagent lot shows elevated complaint activity, however, in-house performance testing was completed which indicates the product is performing as expected.Device history review did not identify any issues associated with the customer¿s observation.A review of ticket trending did not identify any related trend regarding commonalities for complaint lot number and issue.Retained analysis of architect free t4 reagent lot 56026ud00.Testing met acceptance criteria and the product is performing as expected.Labeling review concludes that the issue is adequately addressed.Based on the investigation, no systemic issue or deficiency of the architect free t4 assay was identified.
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