ALINITY I FREE T4 REAGENT KIT
Received Jan 30, 2026 · Event occurred Dec 15, 2025
Report 3005094123-2026-00049 · MDR key 24220469
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P70-30
Lot number
78042UD00
Product problems
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR ONE PATIENT. THE SAMPLE WAS FROZEN BETWEEN EACH MEASUREMENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 12-22 PMOL/L): FIRST SAMPLE (THE PATIENT IS POSITIVE FOR RHEUMATOID FACTOR (RF)), SID 1, INITIAL FREE T4 RESULT 35.3 PMOL/L ((B)(6) 2025), REPEATED 18.1 ((B)(6) 2025), 23.2 PMOL/L ((B)(6) 2025), AND 26.9 PMOL/L ((B)(6) 2025). 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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS PROVIDED, NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.
Additional Manufacturer Narrative
REVIEW OF TRACKING AND TRENDING DATA IDENTIFIED AN INCREASE IN COMPLAINTS FOR THE ALINITY I FREE T4 REAGENT AS WELL AS AN INCREASE IN COMPLAINT ACTIVITY FOR REAGENT LOT 78042UD00. IN-HOUSE TESTING WAS PERFORMED UTILIZING RETAINED KITS OF LOT 78042UD00. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET, INDICATING THAT THE PRODUCT IS PERFORMING AS EXPECTED. A REVIEW IN THE CORRECTIVE AND PREVENTIVE ACTIONS SYSTEM DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND ISSUE. REVIEW OF PRODUCT LABELING CONCLUDED THE CURRENT ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION THE ALINITY I FREE T4 REAGENT LOT 78042UD00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 REAGENT WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS FOR ONE PATIENT. THE SAMPLE WAS FROZEN BETWEEN EACH MEASUREMENT. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE 12-22 PMOL/L): FIRST SAMPLE (THE PATIENT IS POSITIVE FOR RHEUMATOID FACTOR (RF)), SID (B)(6), INITIAL FREE T4 RESULT 35.3 PMOL/L ((B)(6) 2025), REPEATED 18.1 ((B)(6) 2025), 23.2 PMOL/L ((B)(6) 2025), AND 26.9 PMOL/L ((B)(6) 2025). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.