ARCHITECT FREE T4
Received Nov 18, 2025 · Event occurred Oct 30, 2025
Report 3005094123-2025-00582 · MDR key 23583872
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07K65-34
Lot number
70403UD00
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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. COMPLETE INFORMATION FOR SECTION A PATIENT IDENTIFIER AND AGE/GENDER: PATIENT 1 (15-YEAR-OLD FEMALE) WITH SID (B)(6). PATIENT 2 SID, AGE, GENDER NOT PROVIDED.
Description of Event or Problem
THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR TWO PATIENTS. UPON REPEAT TESTING, LOWER RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1 (15-YEAR-OLD FEMALE): SID (B)(6): INITIAL ARCHITECT FREE T4 RESULT = >5.0 NG/DL REPEAT RESULT = 1.24 NG/DL. PATIENT 2: INITIAL ARCHITECT FREE T4 RESULT = 2.40 NG/DL REPEAT RESULT = 0.85 NG/DL. PER THE ARCHITECT FREE T4 PACKAGE INSERT, THE NORMAL RANGE IS 0.70 NG/DL TO 1.48 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ARCHITECT FREE T4 REAGENT LOT 70403UD03. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINTS FOR LIST NUMBER 07K65, HOWEVER, NO TRENDS WERE IDENTIFIED FOR LOT 70403UD03. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. THE OVERALL PERFORMANCE OF ARCHITECT FREE T4 REAGENT WAS REVIEWED USING WORLDWIDE FIELD DATA. 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 WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ARCHITECT FREE T4 REAGENT LOT 70403UD03.
Description of Event or Problem
THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULE FOR TWO PATIENTS. UPON REPEAT TESTING, LOWER RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: PATIENT 1 (15-YEAR-OLD FEMALE): SID (B)(6): INITIAL ARCHITECT FREE T4 RESULT = >5.0 NG/DL REPEAT RESULT = 1.24 NG/DL. PATIENT 2: INITIAL ARCHITECT FREE T4 RESULT = 2.40 NG/DL REPEAT RESULT = 0.85 NG/DL. PER THE ARCHITECT FREE T4 PACKAGE INSERT, THE NORMAL RANGE IS 0.70 NG/DL TO 1.48 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.