ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR TWO PATIENTS. THE SAMPLES WERE REPEATED WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL FT4 RESULT = 25.48 PMOL/L REPEAT RESULT = 14.56 PMOL/L. SID (B)(6) INITIAL FT4 RESULT = 21.52 PMOL/L REPEAT RESULT = 14.33 PMOL/L. REFERENCE RANGE: 9.0-19.05 PMOL/L. ADDITIONAL INFORMATION PROVIDED 13SEPT2025: SID (B)(6) INITIAL FT4 RESULT = 26.44 PMOL/L REPEAT RESULT = 14.54 PMOL/L. SID (B)(6) INITIAL FT4 RESULT = 19.82 PMOL/L REPEAT RESULT = 15.45 PMOL/L. SID (B)(6) INITIAL FT4 RESULT = 23.75 REPEAT RESULT = 14.35 PMOL/L. SID (B)(6) INITIAL FT4 RESULT = >64.35 PMOL/L REPEAT RESULT = 16.39 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETE INFORMATION FOR SECTION A1 PATIENT IDENTIFIER IS SID (B)(6).

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR TWO PATIENTS. THE SAMPLES WERE REPEATED WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), INITIAL FT4 RESULT = 25.48 PMOL/L REPEAT RESULT = 14.56 PMOL/L SID (B)(6), INITIAL FT4 RESULT = 21.52 PMOL/L REPEAT RESULT = 14.33 PMOL/L. REFERENCE RANGE: 9.0-19.05 PMOL/L. ADDITIONAL INFORMATION PROVIDED 13SEPT2025: SID (B)(6), INITIAL FT4 RESULT = 26.44 PMOL/L REPEAT RESULT = 14.54 PMOL/L, SID (B)(6), INITIAL FT4 RESULT = 19.82 PMOL/L REPEAT RESULT = 15.45 PMOL/L, SID (B)(6), INITIAL FT4 RESULT = 23.75 REPEAT RESULT = 14.35 PMOL/L, SID (B)(6), INITIAL FT4 RESULT = >64.35 PMOL/L REPEAT RESULT = 16.39 PMOL/L. ADDITIONAL DATA PROVIDED 17OCT2025: SID (B)(6), INITIAL RESULT = >64.35 PMOL/L REPEAT RESULT = 17.01 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

COMPLETE INFORMATION FOR SECTION A1 PATIENT IDENTIFIER IS SID (B)(6), SID (B)(6), SID (B)(6), SID (B)(6), SID (B)(6), SID (B)(6), AND SID (B)(6). ADDITIONAL PATIENT INFORMATION ADDED (B)(6) 2025. SECTION B5 UPDATED. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, AND LABELING REVIEW. ADDITIONALLY, IN-HOUSE TESTING WAS PERFORMED. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. 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 73465UD01. HOWEVER, TESTING WAS PERFORMED UTILIZING RETAINED KIT AND NOTED THAT ALL TESTING PASSED, INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT NUMBER 73465UD01 AND THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I FREE T4 FOR LOT 73465UD01 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. COMPLETE INFORMATION FOR SECTION A1 PATIENT IDENTIFIER IS SID (B)(6).

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY ELEVATED ALINITY I FREE T4 RESULT FOR TWO PATIENTS. THE SAMPLES WERE REPEATED WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6), INITIAL FT4 RESULT = 25.48 PMOL/L REPEAT RESULT = 14.56 PMOL/L. SID (B)(6), INITIAL FT4 RESULT = 21.52 PMOL/L REPEAT RESULT = 14.33 PMOL/L. REFERENCE RANGE: 9.0-19.05 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.