ALINITY I FREE T4 REAGENT KIT
Received Jul 17, 2025 · Event occurred Jul 5, 2025
Report 3005094123-2025-00362 · MDR key 22532858
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P70-20
Lot number
71236UD00
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR ONE PATIENT. THE SAMPLE WAS REPEATED WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), INITIAL RESULT ON (B)(6) 2025 = 1.66 REPEATED ON (B)(6) 2026 = 1.25, 1.18, 1.19 NG/DL. CUSTOMER REFERENCE RANGE: 0.7 - 1.48 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
THE COMPLAINT INVESTIGATION FOR FALSE ELEVATED ALINITY I FREE T4 RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING DATA FOR THE ALINITY I FREE T4 ASSAY DID IDENTIFY AN INCREASE IN COMPLAINTS. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR REAGENT LOT 71236UD00. HOWEVER, TESTING WAS PERFORMED UTILIZING A RETAINED KIT AND ALL TESTING PASSED INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LIST NUMBER. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 ASSAY FOR LOT 71236UD00 WAS IDENTIFIED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR ONE PATIENT. THE SAMPLE WAS REPEATED WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL RESULT ON (B)(6) 2025 = 1.66 REPEATED ON (B)(6) 2026 = 1.25, 1.18, 1.19 NG/DL. CUSTOMER REFERENCE RANGE: 0.7 - 1.48 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.