ARCHITECT CMV IGG

Additional Manufacturer Narrative

SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. 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 06C15 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06C15, WITH 510 NUMBER K220949.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT CMV IGG RESULTS WHEN COMPARED TO ANOTHER METHOD FOR ONE 50-YEAR-OLD MALE PATIENT WITH HISTORY OF POSITIVE IGG. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, SID (B)(6) ARCHITECT CMV IGG RESULT WAS <6.0 AU/ML (NEGATIVE), CMV IGM WAS NEGATIVE. DIASORIN RESULT WAS POSITIVE 26.8 U (>15U IS POSITIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

SECTION B3 - DATE OF EVENT: THIS SECTION WAS CORRECTED FROM 10FEB2026 TO 11FEB2025. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT CMV IGG ASSAY (LIST NUMBER 06C15) DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS WITH LIST NUMBER 06C15 AND THE COMPLAINT ISSUE. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CMV IGG REAGENT WAS IDENTIFIED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSE NONREACTIVE ARCHITECT CMV IGG RESULTS WHEN COMPARED TO ANOTHER METHOD FOR ONE 50-YEAR-OLD MALE PATIENT WITH HISTORY OF POSITIVE IGG. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2025, SID (B)(6) ARCHITECT CMV IGG RESULT WAS <6.0 AU/ML (NEGATIVE), CMV IGM WAS NEGATIVE. DIASORIN RESULT WAS POSITIVE 26.8 U (>15U IS POSITIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.