Alinity I Free T4 Reagent Kit

Description of Event or Problem

The customer observed falsely elevated Alinity i Free T4 results for one sample. The following data was provided:SID (b)(6).(b)(6) 2026 Initial Free T4 result >5 ng/mL, repeated 1.22 / 1.22 / 1.17 / 1.08 ng/mL.The sample was repeated and manually diluted 1:3, resulted in 0.54 ng/dL. No impact to patient management was reported.

Additional Manufacturer Narrative

Data and information provided by the customer were reviewed and support the complaint issue. A review of tracking and trending did identify an increase in complaint activity for the Alinity i Free T4; however, no trends were identified for lot 87264UD00. A Labeling Review concludes that the complaint issue is adequately addressed. A Device History Record review did not identify any nonconformances, potential nonconformances or deviations associated with the complaint lot and complaint issue. Customer field data was used to assess the performance of the Alinity i Free T4 using worldwide data. The median patient result for the complaint lot is within the established limits, indicating that the reagent lot is performing acceptably in the field. Based on our investigation, no systemic issue or deficiency of the Alinity i Free T4 lot 87264UD00 was identified.