ALINITY I FREE T4 REAGENT KIT
Received Oct 17, 2025 · Event occurred Oct 15, 2025
Report 3005094123-2025-00518 · MDR key 23321458
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P70-30
Lot number
73465UD00
Product problems
- High Test Results
- High Test Results
Patient
33 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED BY THE ALINITY I AM PROCESSING MODULE FOR A 33-YEAR-OLD PREGNANT FEMALE PATIENT. THE SAMPLE WAS REPEATED, YIELDING RESULTS THAT WERE WITHIN THE NORMAL RANGE. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 9.01 TO 19.05 PMOL/L. SID: (B)(6): INITIAL RESULT = 27.83 PMOL/L, REPEAT RESULT = 10.70 PMOL/L. REPEAT RESULTS ON ANOTHER INSTRUMENT = 10.7 PMOL/L AND 10.05 PMOL/L. 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.
Description of Event or Problem
CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 33-YEAR-OLD PREGNANT FEMALE PATIENT. THE SAMPLE WAS REPEATED, YIELDING RESULTS THAT WERE WITHIN THE NORMAL RANGE. THE FOLLOWING DATA WAS PROVIDED: CUSTOMER¿S REFERENCE RANGE: 9.01 TO 19.05 PMOL/L SID (B)(6): INITIAL RESULT = 27.83 PMOL/L, REPEAT RESULT = 10.70 PMOL/L REPEAT RESULTS ON ANOTHER INSTRUMENT = 10.7 PMOL/L AND 10.05 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING DATA IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR THE ALINITY FREE T4 ASSAY AS WELL AS AN INCREASE IN COMPLAINT ACTIVITY FOR REAGENT LOT 73465UD00, HOWEVER TESTING WAS PERFORMED USING AN IN-HOUSE RETAIN KIT OF LOT 73465UD00. TESTING MET ACCEPTANCE CRITERIA, INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. A REVIEW IN THE CORRECTIVE AND PREVENTIVE ACTIONS SYSTEM DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 REAGENT LOT 73465UD00 WAS IDENTIFIED.