ALINITY I FREE T4 REAGENT KIT
Received Feb 4, 2026 · Event occurred Jan 25, 2026
Report 3005094123-2026-00052 · MDR key 24257086
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P70-77
Lot number
82597UD01
Product problems
- High Test Results
Patient
NA · Unknown
- 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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P70-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P70, 510K K173122. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT PROVIDED.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED ON AN ALINITY I PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 9.01-19.05 PMOL/L): INITIAL RESULT (B)(6) = 22.26 PMOL/L, REPEAT RESULT = 15.69 PMOL/L, REPEAT RESULT AFTER CALIBRATION (B)(6) = 16.42 PMOL/L, REPEAT RESULT (B)(6) = 16.73 PMOL/L . THERE WAS NO IMPACT TO PATIENT MANAGEMENT.
Additional Manufacturer Narrative
A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I FREE T4 REAGENT LOT 82597UD01 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 82597UD01. HOWEVER, TESTING WAS PERFORMED UTILIZING RETAINED KITS OF LOT 82597UD00 AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOTS ARE PERFORMING AS EXPECTED. THE OVERALL PERFORMANCE WAS REVIEWED AND SHOWED THAT THE MEDIAN PATIENT RESULT FOR THE REAGENT LOT 82597UD FALLS WITHIN THE ESTABLISHED BASELINE, INDICATING THE REAGENT LOT IS PERFORMING ACCEPTABLY ON MARKET. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I FREE T4 REAGENT LOT 82597UD01.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED ON AN ALINITY I PROCESSING MODULE FOR ONE SAMPLE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 9.01-19.05 PMOL/L): INITIAL RESULT (B)(6) = 22.26 PMOL/L, REPEAT RESULT = 15.69 PMOL/L, REPEAT RESULT AFTER CALIBRATION (B)(6) = 16.42 PMOL/L, REPEAT RESULT (B)(6) = 16.73 PMOL/L . THERE WAS NO IMPACT TO PATIENT MANAGEMENT.