ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: REFERENCE RANGE 9-19 PMOL/L. ON (B)(6) 2025, SID (B)(6), INITIAL FREE T4 RESULT= 52.5 PMOL/L; (B)(6) 2025, REPEAT RESULT= >64 PMOL/L; ON (B)(6) 2025, REPEAT RESULT= 29.9 PMOL/L. THE PATIENT HAD ANOTHER SAMPLE COLLECTED AT THE ED, RESULT= 18.3 PMOL/L. ADDITIONAL LAB RESULT: (B)(6) 2025, TSH RESULT= 0.313 MIU/L THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ALINITY I FREE T4 REAGENT LOT: 76559UD00 TO ADDRESS THE CUSTOMER¿S OBSERVATION OF FALSELY ELEVATED RESULTS. A REVIEW OF TRACKING AND TRENDING DID IDENTIFY AN INCREASE IN COMPLAINTS FOR LIST NUMBER 07P70, HOWEVER, NO TRENDS WERE IDENTIFIED FOR LOT 76559UD00. A REVIEW IN THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) SYSTEM DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ASSAY. IN-HOUSE SPECIFICITY TESTING OF A RETAINED KIT OF LOT 76559UD00 WAS COMPLETED. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I FREE T4 REAGENT FOR LOT 76559UD00 WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: REFERENCE RANGE 9-19 PMOL/L ON (B)(6) 2025, SID (B)(6), INITIAL FREE T4 RESULT= 52.5 PMOL/L; (B)(6) 2025, REPEAT RESULT= >64 PMOL/L; (B)(6) 2025, REPEAT RESULT= 29.9 PMOL/L. THE PATIENT HAD ANOTHER SAMPLE COLLECTED AT THE ED, RESULT= 18.3 PMOL/L. ADDITIONAL LAB RESULT: (B)(6) 2025, TSH RESULT= 0.313 MIU/L. THERE WAS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.