ARCHITECT FREE T4

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07K65, 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 A FALSELY ELEVATED ARCHITECT FREE T4 RESULT GENERATED FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 9.01-19.05 PMOL/L): INITIAL RESULT = 19.89 PMOL/L, REPEAT = 16.91 PMOL/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.