ALINITY I FREE T4 REAGENT KIT
Received Nov 11, 2025 · Event occurred Oct 23, 2025
Report 3005094123-2025-00568 · MDR key 23522121
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P70-77
Lot number
75088UD01
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 A FALSELY ELEVATED ALINITY I FREE T4 RESULT ON A PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. RESULTS PROVIDED: 19.69 / 12.31 NG/L (REFERENCE RANGE: 7-14.8 NG/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING DATA IDENTIFIED AN INCREASE IN COMPLAINTS FOR THE ALINITY I FREE T4 ASSAY, AS WELL AS AN INCREASE IN COMPLAINT ACTIVITY FOR REAGENT LOT 75088UD01. HOWEVER, TESTING PERFORMED USING A RETAINED KIT FROM LOT 75088UD01 SHOWED THAT ALL RESULTS PASSED, INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. A DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT OR ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 ASSAY, LOT 75088UD01 WAS IDENTIFIED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.
Description of Event or Problem
THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT ON A PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. RESULTS PROVIDED: 19.69 / 12.31 NG/L (REFERENCE RANGE: 7-14.8 NG/L). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.