ALINITY I TOXO IGG REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I TOXO IGG FOR ONE FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED:(b)(6) 2026, SID (b)(6).INITIAL TOXO IGG RESULT= 5.8 IU/ML; REPEAT RESULT= 5.8 IU/ML; REPEAT RESULT (ANALYZER AI24419) = 5.7 IU/ML. THE PATIENT RESULTS ARE HISTORICALLY NEGATIVE. THE SAMPLE WAS SENT TO ANOTHER LAB AND PERFORMED ON THE BIORAD PLATFORM WITH NEGATIVE RESULTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P45-22/32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P45-40/45, 510K/PMA/BLA= K210596.THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P45-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P45-40 / 45, WITH 510K NUMBER K210596.