ALINITY I FREE T4 REAGENT KIT
Received Jun 25, 2026 · Event occurred Jun 16, 2026
Report 3005094123-2026-00315 · MDR key 25628919
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P70-77
Lot number
82198UD01
Product problems
- High Test Results
Patient
50 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P70-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P70, WITH 510K NUMBER K173122.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 (FT4) RESULT WAS GENERATED ON THE ALINITY I PROCESSING MODULE. THE FOLLOWING DATA WAS PROVIDED (FREE T4 REFERENCE RANGE: 9.01-19.05 PMOL/L): SAMPLE 3: SID (B)(6) (50-YEAR-OLD, FEMALE): INITIAL FT4 RESULT = 25.04 PMOL/L. REPEAT FT4 RESULT = 17.69 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.