ALINITY I FREE T4 REAGENT KIT
Received Oct 2, 2025 · Event occurred Aug 14, 2025
Report 3005094123-2025-00497 · MDR key 23200099
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07P70-20
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED ERRATIC ALINITY I FREE T4 FOR MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 9 - 19 PMOL/L): (B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6)= 7.8 PMOL/L; REPEAT RESULT= 11.7 PMOL/L, (B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6)= 33.2 PMOL/L; REPEAT RESULT= 12.1 PMOL/L, (B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6)= 27.8 PMOL/L; REPEAT RESULT= 18.8 PMOL/L, (B)(6) 2025, SID(B)(6) , INITIAL FT4 RESULT (B)(6)= 35.8 PMOL/L; REPEAT RESULT= 15.4 PMOL/L, (B)(6) 2025, SID(B)(6) , INITIAL FT4 RESULT (B)(6)= 29.9 PMOL/L; REPEAT RESULT= 16 PMOL/L, (B)(6) 2025, SID(B)(6) , INITIAL FT4 RESULT (B)(6)= 25 PMOL/L; REPEAT RESULT= 18.6 PMOL/L, (B)(6) 2025, SID(B)(6) , INITIAL FT4 RESULT (B)(6)= 24.9 PMOL/L; REPEAT RESULT= 17.9 PMOL/L, (B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6)= 65 PMOL/L; REPEAT RESULT= 17.3 PMOL/L. (B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6)= 29.2 PMOL/L; REPEAT RESULT= 17 PMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I FREE T4 REAGENT WITH UNKNOWN LOT. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I FREE T4 REAGENT.
Description of Event or Problem
THE CUSTOMER OBSERVED ERRATIC ALINITY I FREE T4 FOR MULTIPLE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 9 - 19 PMOL/L): ON (B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6) = 7.8 PMOL/L; REPEAT RESULT= 11.7 PMOL/L ON (B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6) = 33.2 PMOL/L; REPEAT RESULT= 12.1 PMOL/L ON (B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6) = 27.8 PMOL/L; REPEAT RESULT= 18.8 PMOL/L ON (B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6) = 35.8 PMOL/L; REPEAT RESULT= 15.4 PMOL/L ON(B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6) = 29.9 PMOL/L; REPEAT RESULT= 16 PMOL/L ON (B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6) = 25 PMOL/L; REPEAT RESULT= 18.6 PMOL/L ON (B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6) = 24.9 PMOL/L; REPEAT RESULT= 17.9 PMOL/L ON(B)(6) 2025, SID (B)(6), INITIAL FT4 RESULT (B)(6) = 65 PMOL/L; REPEAT RESULT= 17.3 PMOL/L ON (B)(6) 2025, SID (B)(6) INITIAL FT4 RESULT (B)(6) = 29.2 PMOL/L; REPEAT RESULT= 17 PMOL/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.
Additional Manufacturer Narrative
SECTION A1 - PATIENT IDENTIFIER: SAMPLE IDS = (B)(6) AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.