ALINITY I CMV IGG REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED FALSE REACTIVE ALINITY I CMV IGG RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A PREGNANT FEMALE PATIENT. THE RESULT WAS INCONSISTENT WITH THE PATIENT¿S PRIOR RESULTS. THE SAMPLE WAS RETESTED, WHICH YIELDED NONREACTIVE RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). ON (B)(6) 2026 ALINITY I CMV IGG RESULT = 135 AU/ML ON (B)(6) 2026 REPEAT RESULTS = 0.0 AU/ML, 0.5 AU/ML, 0.4 AU/ML, 0.0 AU/ML ON (B)(6) 2025 SID (B)(6) RESULT: <6 AU/ML PER THE ALINITY CMV IGG PACKAGE INSERT, INTERPRETATION OF RESULTS SECTION: SPECIMENS WITH CONCENTRATION VALUES = 6.0 AU/ML ARE CONSIDERED REACTIVE AND < 6.0 AU/ML ARE CONSIDERED NONREACTIVE. NO IMPACT TO PATIENT MANAGEMENT WAS 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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P42-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33, WITH 510K NUMBER K220949.