ALINITY I CMV IGG REAGENT KIT

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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P42-22, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P42-24, AND A 510K NUMBER OF K220949.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I CMV IGG RESULTS FOR A 30-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (<6.0 AU/ML IS NONREACTIVE, >/=6.0 AU/ML IS REACTIVE): SAMPLE ID (B)(6) INITIAL RESULT, ON 11APR2026, WAS 28.5 AU/ML. A DIFFERENT SAMPLE FROM THE PATIENT WAS TESTED ON 15APR2026 AND THE RESULT WAS 30.25 AU/ML. THE PATIENT SAMPLE WAS TESTED AT OTHER LABORATORIES USING ROCHE ASSAYS AND THE RESULTS WERE: LABORATORY 1: IGG <0.25 U/ML; IGM = 0.22 (THRESHOLD < 0.7); LABORATORY 2: IGG <0.25 U/ML; IGM = 0.17. THE AVIDITY RESULT, TESTED USING A DIASORIN LIAISON ASSAY, WAS <0.150, WHICH IS NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.