ALINITY I FREE T4 REAGENT KIT
Received Sep 9, 2025 · Event occurred Jul 11, 2025
Report 3005094123-2025-00433 · MDR key 23004654
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
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) INITIAL RESULT = 24.81 PMOL/L, REPEAT RESULTS ON A DIFFERENT ALINITY = 16.53 PMOL/L AND REPEAT RESULT ON SAME ALINITY = 16.10 PMOL/L. 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 73465UD00. HOWEVER, TESTING WAS PERFORMED UTILIZING A RETAINED KIT AND ALL TESTING PASSED INDICATING THE REAGENT LOT 73465UD00 IS PERFORMING AS EXPECTED. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS WITH THE 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 73465UD00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR ONE SAMPLE.THE FOLLOWING RESULTS WERE PROVIDED:(B)(6) 2025 SID (B)(6) INITIAL RESULT = 24.81 PMOL/L, REPEAT RESULTS ON A DIFFERENT ALINITY = 16.53. PMOL/L AND REPEAT RESULT ON SAME ALINITY = 16.10 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.