ALINITY I FREE T4 REAGENT KIT
Received Dec 24, 2025 · Event occurred Dec 23, 2025
Report 3005094123-2025-00665 · MDR key 23888423
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P70-30
Lot number
76559UD00
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I FREE T4 REAGENT, LOT 76559UD00 TO ADDRESS THE CUSTOMER¿S OBSERVATION OF FALSELY ELEVATED RESULTS. A REVIEW OF TRACKING AND TRENDING IDENTIFIED AN INCREASE IN COMPLAINTS FOR THE ALINITY I FREE T4 REAGENT AS WELL AS AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 76559UD00. HOWEVER, TESTING WAS PERFORMED UTILIZING RETAINED KITS OF LOT 76559UD00 AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOTS ARE PERFORMING AS EXPECTED. A REVIEW IN THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) SYSTEM DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ASSAY. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 REAGENT FOR LOT 76559UD00 WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR TWO SAMPLES. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 SAMPLE 1 SID (B)(6) INITIAL RESULT >64.350 PMOL/L, REPEATED 10.341 AND 12.188 PMOL/L, TSH 0.845 MIU/L SERUM LIPAEMIC RESULT 61.00 INDEX (1+). SAMPLE 2 SID (B)(6) INITIAL RESULT >64.350 PMOL/L, REPEATED 49.596 / 55.342 / 43.883 PMOL/L, TSH RESULT <0.008 MIU/L SERUM HEMOLYSE RESULT 166 INDEX (2+). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR TWO SAMPLES. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025 SAMPLE 1 SID (B)(6) INITIAL RESULT >64.350 PMOL/L, REPEATED 10.341 AND 12.188 PMOL/L, TSH 0.845 MIU/L SERUM LIPAEMIC RESULT 61.00 INDEX (1+). SAMPLE 2 SID (B)(6) INITIAL RESULT >64.350 PMOL/L, REPEATED 49.596 / 55.342 / 43.883 PMOL/L, TSH RESULT <0.008 MIU/L SERUM HEMOLYSE RESULT 166 INDEX (2+). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.