ARCHITECT FREE T4
Received Dec 30, 2025 · Event occurred Dec 15, 2025
Report 3005094123-2025-00671 · MDR key 23924383
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07K65-77
Lot number
73030UD02
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
54 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
FURTHER INFORMATION PROVIDED ON 05JAN2026: UPDATED SECTION B5 DESCRIBE EVENT OR PROBLEM: CORRECTION ISSUE WITH ARCHITECT FT4 AND NOT ALINITY I FT4. THE CUSTOMER IS NO LONGER QUESTIONING THE ARCHITECT FREE T4 (FT4) RESULTS. BASED UPON THIS NEW INFORMATION, THIS COMPLAINT IS NO LONGER A REPORTABLE EVENT, THEREFORE NO FURTHER REPORT WILL BE PROVIDED ARCHITECT FREE T4 (FT4).
Description of Event or Problem
THE CUSTOMER OBSERVED IMPRECISE ARCHITECT FREE T4 (FT4) RESULTS GENERATED ON A 54YRS OLD MALE PATIENT DRAWN DIFFERENT TIME. THE RESULTS PROVIDED WERE: ON (B)(6) 2025 SID (B)(6): FT4 INITIAL=17.42 PMOL/L /REPEATED AT ANOTHER FACILITY=18.01 PMOL/L. REDRAWN SAME PATIENT AND REPEATED AS BELOW: SID (B)(6): FT4 INITIAL=19.64 PMOL/L /REPEATED AT ANOTHER FACILITY=19.96 PMOL/L. LABORATORY REFERENCE RANGE FOR FT4=9.01 TO 19.05 PMOL/L. BOTH SPECIMENS WERE REPEATED AT ANOTHER FACILITY FOR TROUBLESHOOTING PURPOSES AND WERE NOT USED FOR PATIENT MANAGEMENT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. FURTHER INFORMATION PROVIDED ON 05JAN2026: THE CUSTOMER IS NO LONGER QUESTIONING THE ARCHITECT FREE T4 (FT4) RESULTS. BASED UPON THIS NEW INFORMATION, THIS COMPLAINT IS NO LONGER A REPORTABLE EVENT, THEREFORE NO FURTHER REPORT WILL BE PROVIDED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETE INFORMATION FOR SECTION A PATIENT INFORMATION, 1. PATIENT IDENTIFIER = SID= (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
Description of Event or Problem
THE CUSTOMER OBSERVED IMPRECISE ALINITY I FREE T4 (FT4) RESULTS GENERATED ON A 54YRS OLD MALE PATIENT DRAWN DIFFERENT TIME. THE RESULTS PROVIDED WERE: ON (B)(6) 2025, SID (B)(6): FT4 INITIAL=17.42 PMOL/L /REPEATED AT ANOTHER FACILITY=18.01 PMOL/L. REDRAWN SAME PATIENT AND REPEATED AS BELOW: SID (B)(6): FT4 INITIAL=19.64 PMOL/L /REPEATED AT ANOTHER FACILITY=19.96 PMOL/L. LABORATORY REFERENCE RANGE FOR FT4=9.01 TO 19.05 PMOL/L. BOTH SPECIMENS WERE REPEATED AT ANOTHER FACILITY FOR TROUBLESHOOTING PURPOSES AND WERE NOT USED FOR PATIENT MANAGEMENT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.