ARCHITECT FREE T4
Received Sep 19, 2025 · Event occurred Sep 6, 2025
Report 3005094123-2025-00463 · MDR key 23097538
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07K65-78
Lot number
69104UD03
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, SID (B)(6) (FEMALE PATIENT): INITIAL RESULT = 34.43 PMOL/L, REPEAT = 15.54 PMOL/L. ON (B)(6) 2025, SID (B)(6) (18-YEAR-OLD FEMALE PATIENT): INITIAL RESULT = 25.20 PMOL/L, REPEAT = 15.09 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
COMPLETED INFORMATION FOR SECTION A1: PATIENT 1: FEMALE, SID (B)(6), PATIENT 2: 18-YEAR-OLD, FEMALE, SID (B)(6). 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.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ARCHITECT FREE T4<PRODUCT NAME, 07K65-74, LONGFORD TO ARCHITECT I2000SR PROCESSING MODULE, 03M74-02, IRVING. MDR NUMBER 3016438761-2025-00592 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.
Description of Event or Problem
THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025, SID (B)(6) (FEMALE PATIENT): INITIAL RESULT = 34.43 PMOL/L, REPEAT = 15.54 PMOL/L. (B)(6) 2025, SID (B)(6) (18-YEAR-OLD FEMALE PATIENT): INITIAL RESULT = 25.20 PMOL/L, REPEAT = 15.09 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.