ARCHITECT FREE T4
Received Dec 23, 2025 · Event occurred Dec 10, 2025
Report 3005094123-2025-00661 · MDR key 23881825
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07K65-29
Lot number
77507UD00
Product problems
- High Test Results
- High Test Results
Patient
47 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COMPLAINT INVESTIGATION FOR A FALSELY ELEVATED ARCHITECT FREE T4 RESULT INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINTS FOR LIST NUMBER 07K65, HOWEVER, NO TRENDS WERE IDENTIFIED FOR THE COMPLAINT LOT. USING WORLDWIDE FIELD DATA GATHERED VIA FROM CUSTOMERS, THE PERFORMANCE OF REAGENT LOT 77507UD00 WAS EVALUATED AND IS PERFORMING SIMILAR TO OTHER REAGENT LOTS IN THE FIELD, CONFIRMING THERE WAS NO SYSTEMIC ISSUE. THE MEDIAN VALUE OF THE COMPLAINT LOT NUMBER IS WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO HISTORICAL REAGENT LOT PERFORMANCE. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE LIST NUMBER AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT FREE T4 REAGENT, LOT NUMBER 77507UD00, WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR A 47-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 0.700-1.480 NG/DL) SAMPLE ID (B)(6) INITIAL RESULT WAS >5.00, REPEAT RESULT WAS 1.19 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A1 - PATIENT IDENTIFIER COMPLETE ENTRY = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
Description of Event or Problem
THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT FREE T4 RESULT FOR A 47-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 0.700-1.480 NG/DL) SAMPLE ID (B)(6) INITIAL RESULT WAS >5.00, REPEAT RESULT WAS 1.19 NG/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.