ALINITY I FREE T4 REAGENT KIT
Received Sep 30, 2025 · Event occurred Jan 1, 2025
Report 3005094123-2025-00489 · MDR key 23180646
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P70-77
Lot number
73465UD01
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
ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 (FT4) RESULTS FROM (B)(6) 2025 THROUGH (B)(6) 2025 ON 161 PATIENTS. THE RESULTS PROVIDED WERE: INITIAL RESULTS=> 19.05 /REPEATED=< 19.05; DIFFERENCE BETWEEN TWO RESULTS=> 15%. NO INDIVIDUAL PATIENT RESULTS PROVIDED BY THE CUSTOMER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.
Additional Manufacturer Narrative
THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, AND LABELING REVIEW, IN-HOUSE TESTING WAS PERFORMED FOR ALINITY I FREE T4 REAGENT LOT 73465UD01. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING DATA IDENTIFIED AN INCREASE IN COMPLAINTS FOR THE ALINITY I FREE T4 ASSAY AS WELL AS AN INCREASE IN COMPLAINT ACTIVITY FOR REAGENT LOT 73465UD01. HOWEVER, TESTING WAS PERFORMED UTILIZING RETAINED KIT AND NOTED THAT 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 LOT NUMBER 73465UD01 AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 FOR LOT 73465UD01 WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 (FT4) RESULTS FROM (B)(6) 2025 THROUGH (B)(6) 2025 ON 161 PATIENTS. THE RESULTS PROVIDED WERE: INITIAL RESULTS=> 19.05 /REPEATED=< 19.05; DIFFERENCE BETWEEN TWO RESULTS=> 15% NO INDIVIDUAL PATIENT RESULTS PROVIDED BY THE CUSTOMER. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.