ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN-HOUSE TESTING OF ALINITY I FREE T4 REAGENT KIT, LOT 75641UD00. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I FREE T4 ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 75641UD00. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE COMPLAINT LOT WAS PERFORMED. TESTING MET ACCEPTANCE CRITERIA AND THE PRODUCT IS PERFORMING AS EXPECTED. DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LIKELY CAUSE LIST NUMBER AND COMPLAINT ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ALINITY I FREE T4 REAGENT KIT, LOT 75641UD00.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I FREE T4 RESULTS FOR A 52-YEAR-OLD MALE PATIENT WHO HAS GRAVES¿ DISEASE. RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025, SID (B)(6); INITIAL RESULT = < 0.42 NG/DL, REPEAT RESULTS FROM ANOTHER ANALYZER (B)(6): <0.42 NG/DL, PREVIOUS RESULT WAS 1.3 NG/DL. THE CUSTOMER USES REFERENCE RANGE: 0.71-1.51 NG/DL. UPDATES 03/24/2026: AFTER FURTHER REVIEW, FREE T4 RESULTS WERE 0.42 NG/DL ON (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I FREE T4 RESULTS FOR A 52-YEAR-OLD MALE PATIENT WHO HAS GRAVES¿ DISEASE. RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2025, SID (AI31369); INITIAL RESULT = < 0.42 NG/DL, REPEAT RESULTS FROM ANOTHER ANALYZER (B)(6): <0.42 NG/DL, PREVIOUS RESULT WAS 1.3 NG/DL. THE CUSTOMER USES REFERENCE RANGE: 0.71-1.51 NG/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

COMPLETE INFORMATION FOR SECTION A, PATIENT SID: (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED; NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P70 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P70, WITH 510K NUMBER K173122.