ALINITY I FREE T4 REAGENT KIT
Received Feb 16, 2026 · Event occurred Feb 9, 2026
Report 3005094123-2026-00073 · MDR key 24344769
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P70-20
Lot number
78124UD00
Product problems
- High Test Results
Patient
95 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS GENERATED ON THE ALINITY I PROCESSING MODULES FOR ONE PATIENT WHICH WAS NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA PROVIDED. (B)(6) MALE, SID (B)(6), INITIAL RESULT 27.6 PMOL/L, REPEAT RESULT =17.4 PMOL/L ON (B)(6). THE CUSTOMER REFERENCE RANGE: 9.0 TO 19.0 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINTS FOR THE ALINITY I FREE T4 ASSAY (LIST NUMBER 07P70), HOWEVER, NO TRENDS WERE IDENTIFIED FOR LOT 78124UD00. THE OVERALL PERFORMANCE OF THE ALINITY I FREE T4 REAGENTS IN THE FIELD WAS REVIEWED USING WORLDWIDE DATA. THE REVIEW SHOWS THAT THE RESULT FOR THE MEDIAN POPULATION FOR LOT NUMBER 78124UD00 IS WITHIN ESTABLISHED LIMITS, INDICATING THE REAGENT LOT IS PERFORMING ACCEPTABLY ON MARKET. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS WITH LOT NUMBER 78124UD00 AND THE COMPLAINT ISSUE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER¿S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I FREE T4 REAGENT, LOT NUMBER 78124UD00.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS GENERATED ON THE ALINITY I PROCESSING MODULES FOR ONE PATIENT WHICH WAS NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA PROVIDED. (B)(6) MALE, SID (B)(6) , INITIAL RESULT 27.6 PMOL/L, REPEAT RESULT =17.4 PMOL/L ON (B)(6). THE CUSTOMER REFERENCE RANGE: 9.0 TO 19.0 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.