ALINITY I FREE T4 REAGENT KIT

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, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US WITH THE SAME LIST NUMBER, AND A 510K/PMA/BLA NUMBER OF K173122.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I FREE T4 RESULTS GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 0.70¿1.48 NG/DL): INITIAL RESULT = 1.58 NG/DL, REPEAT RESULTS = 0.91 NG/DL, 0.91 NG/DL. ADDITIONAL LABORATORY RESULTS PROVIDED: TSH RESULT = 1.0147 UIU/ML (REFERENCE RANGE 0.250-4.940 UIU/ML). FT3 2.61 PG/ML (REFERENCE RANGE 1.58-3.91 PG/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.