ALINITY I PROLACTIN REAGENT KIT

Additional Manufacturer Narrative

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 7P66 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P66, WITH 510K EXEMPT. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I PROLACTIN RESULTS FOR A 24-YEAR-OLD FEMALE PATIENT (SID (B)(6)) WITH IRREGULAR MENSTRUATION EXPERIENCED THREE EPISODES OF IRREGULAR BLEEDING ON MAY 1ST, 19TH, AND 25TH. ON (B)(6) 2026 ALINITY I PROLACTIN RESULT WAS 40.01 NG/ML (REFERENCE RANGE: 5.18-26.53). ON (B)(6) 2026 PROLACTIN RESULT FROM ANOTHER HOSPITAL WAS 13.29 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.