ARCHITECT FREE T4
Received Nov 26, 2025 · Event occurred Oct 21, 2025
Report 3005094123-2025-00601 · MDR key 23662193
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07K65-29
Lot number
75463UD00
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. THE CUSTOMER REPORTED RESULTS OVER THE UPPER LIMIT AND WHEN REPEATED THE RESULTS WERE WITHIN NORMAL RANGE. (CUSTOMER REFERENCE RANGE: FREE T4 REFERENCE RANGE 0.7¿1.48). THE CUSTOMER FURTHER REPORTED THIS ALSO INCLUDED A SAMPLE FROM A MALE PATIENT NOT RECEIVING THYROID TREATMENT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. UPDATE: THE CUSTOMER PROVIDED FURTHER INFORMATION ON (B)(6) 2025: THE CUSTOMER REPORTED THAT THEY INCORRECTLY MADE THE BUFFER SOLUTION WITHOUT ADDING CONCENTRATED DILUTION BUFFER. THE CUSTOMER DOES NOT BELIEVE THAT THE PATIENT RESULTS ISSUE AND CONTROLS ISSUE WAS DUE TO AN ABBOTT DEVICE BUT RATHER THE CUSTOMER BELIEVES THAT THIS EVENT WAS CAUSED BY THE INCORRECTLY MADE BUFFER SOLUTION.
Additional Manufacturer Narrative
SECTION B5 WAS UPDATED WITH ADDITIONAL INFORMATION. THE CUSTOMER DOES NOT BELIEVE THAT THE PATIENT RESULTS ISSUE AND CONTROLS ISSUE WAS DUE TO AN ABBOTT DEVICE BUT RATHER THE CUSTOMER BELIEVES THAT THIS EVENT WAS CAUSED BY THE INCORRECTLY MADE BUFFER SOLUTION. BASED UPON THIS NEW INFORMATION, THIS COMPLAINT IS NO LONGER A REPORTABLE EVENT.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT FREE T4. THE CUSTOMER REPORTED RESULTS OVER THE UPPER LIMIT AND WHEN REPEATED THE RESULTS WERE WITHIN NORMAL RANGE. (CUSTOMER REFERENCE RANGE: FREE T4 REFERENCE RANGE 0.7¿1.48). THE CUSTOMER FURTHER REPORTED THIS ALSO INCLUDED A SAMPLE FROM A MALE PATIENT NOT RECEIVING THYROID TREATMENT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.