ALINITY I FREE T4 REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I FREE T4 RESULT GENERATED FOR A 25-YEAR-OLD PREGNANT FEMALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (NON-GRAVID REFERENCE RANGE 11-17.7 PMOL/L, FIRST TRIMESTER: 11.3-17.8 PMOL/L, SECOND TRIMESTER:9.3-15.2 PMOL/L, THIRD TRIMESTER: 7.9-14.1 PMOL/L): SAMPLE ID: (B)(6) INITIAL RESULT = >64.35 PMOL/L, REPEAT RESULTS = 12.98 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 07P70-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 07P70, 510K K173122. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.