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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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/-33.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I CMV IGG RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR ONE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: < 6.0 AU/ML IS NONREACTIVE, >/= 6.0 AU/ML IS REACTIVE): ON (B)(6) 2025 AT 14:20, SID (B)(6): CMV IGG INITIAL RESULT = 50.2 AU/ML. ON (B)(6) 2025 AT 16:11, SID (B)(6): CMV IGG REPEAT RESULT = 0.6 AU/ML. ON (B)(6) 2025 AT 16:12, SID (B)(6): CMV IGG REPEAT RESULT = 0.6 AU/ML. OTHER TESTING PROVIDED: CMV IGM = NEGATIVE. THE REASON FOR REPEATING THE CMV IGG TEST WAS BECAUSE IN (B)(6) 2025, THE PATIENT WAS NEGATIVE FOR CMV IGG AND CMV IGM. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE REACTIVE ALINITY I CMV IGG RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR ONE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: < 6.0 AU/ML IS NONREACTIVE, >/= 6.0 AU/ML IS REACTIVE): ON (B)(6) 2025 AT 14:20, SID: (B)(6): CMV IGG INITIAL RESULT = 50.2 AU/ML. ON (B)(6) 2025 AT 16:11, SID: (B)(6): CMV IGG REPEAT RESULT = 0.6 AU/ML. ON (B)(6) 2025 AT 16:12, SID: (B)(6): CMV IGG REPEAT RESULT = 0.6 AU/ML. OTHER TESTING PROVIDED: CMV IGM = NEGATIVE. THE REASON FOR REPEATING THE CMV IGG TEST WAS BECAUSE IN JANUARY 2025, THE PATIENT WAS NEGATIVE FOR CMV IGG AND CMV IGM. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING OF A RETAINED REAGENT KIT LOT: 67106FZ00. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I CMV IGG ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT: 67106FZ00. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCE'S OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT AND COMPLAINT ISSUE. CLINICAL SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAIN KIT OF ALINITY I CMV IGG REAGENT LOT: 67106FZ00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I CMV IGG REAGENT LOT: 67106FZ00 WAS IDENTIFIED.