ARCHITECT FREE T4
Received Jan 26, 2026 · Event occurred Dec 18, 2025
Report 3005094123-2026-00038 · MDR key 24180122
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07K65-29
Lot number
77507UD00
Product problems
- High Test Results
Patient
80 YR · Female
- 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. SEE RELATED REPORT NUMBER 3005094123-2026-00039-00.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR ONE FEMALE PATIENT IN HER EIGHTIES WHO IS NOT ON ANY THYROID TREATMENT WHEN COMPARED TO ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: PATIENT ARCHITECT RESULTS FROM (B)(6) 2025: FT4 2.10 NG/DL. OTHER RESULTS = FT3 2.75 PG/ML TSH 3.16 UIU/ML. PATIENT RESULTS FROM ANOTHER METHOD(CLEIA): FT4 0.97 NG/DL. OTHER RESULTS = FT3 2.60 PG/ML TSH 7.10 UIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT FREE T4 DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, NO TRENDS WERE IDENTIFIED FOR LOT 77507UD00. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER. THE OVERALL PERFORMANCE OF THE ARCHITECT FREE T4 REAGENT IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE MEDIAN POPULATION RESULT FOR THE COMPLAINT LOT IS WITHIN ESTABLISHED LIMITS, INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY IN THE FIELD. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT FREE T4 LOT 77507UD00 WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR ONE FEMALE PATIENT IN HER EIGHTIES WHO IS NOT ON ANY THYROID TREATMENT WHEN COMPARED TO ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED: PATIENT ARCHITECT RESULTS FROM (B)(6) 2025: FT4 2.10 NG/DL OTHER RESULTS = FT3 2.75 PG/ML TSH 3.16 UIU/ML PATIENT RESULTS FROM ANOTHER METHOD(CLEIA): FT4 0.97 NG/DL OTHER RESULTS = FT3 2.60 PG/ML TSH 7.10 UIU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.