ALINITY I CMV IGG REAGENT KIT

Additional Manufacturer Narrative

ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. SECTION A1 PATIENT IDENTIFIER COMPLETE SID: (B)(6). THE EVALUATION OF COMPLAINT DATA FOR THE PRODUCT AND LIKELY CAUSE ALINITY I CMV IGG LOT# 64302FN00 IDENTIFIED HIGHER COMPLAINT ACTIVITY THAN EXPECTED, BUT TRENDING REVIEW DETERMINED THERE WERE NO TRENDS FOR THE ISSUE FOR THIS PRODUCT. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. CLINICAL SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 64302FN00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. BASED ON THE INVESTIGATION, A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P42-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24, WITH 510K/PMA/BLA NUMBER K220949.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I CMV IGG RESULT ON A 15-YR OLD MALE PATIENT. RESULTS PROVIDED: (B)(6) 2025 , SID (B)(6) , CMV IGG = 9.2 / 1.4 / 17.4 AU/ML, ANOTHER LABORATORY = 1.6 AU/ML . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.