Alinity I Free T4 Reagent Kit
Received Jun 18, 2026 · Event occurred Jun 3, 2026
Report 3005094123-2026-00293 · MDR key 25548783
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P70-30
Lot number
82597UD00
Product problems
- Imprecise or Erratic Results
Patient
12 MO · 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.
Description of Event or Problem
THE CUSTOMER OBSERVED ERRATIC ALINITY I FREE T4 RESULTS FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED: (CUSTOMER REFERENCE RANGE 9 PMOL/L TO 19.05 PMOL/L): SID (B)(6). FIRST RUN: 21.29 PMOL/L (B)(6) 2026 TIME 09:33AM) SECOND RUN: 18.36 PMOL/L (B)(6) 2026 TIME 10:15AM) THIRD RUN: 18.00 PMOL/L (B)(6) 2026 TIME 12:06PM). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.