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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P42-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33, WITH 510K/PMA/BLA NUMBER K220949. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY POSITIVE ALINITY I CMV IGG RESULTS FOR TWO PREGNANT FEMALE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: BOTH PATIENT'S INITIAL RESULTS ON (B)(6) 2025 = NEGATIVE RESULT (NO SPECIFIC RESULT PROVIDED). (B)(6) 2025 RESULT = >200 AU/ML, SECOND RESULT >200 AU/ML CONFIRMED ON THE OTHER INSTRUMENT IN THE LABORATORY FOR TROUBLESHOOTING PURPOSES ONLY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY POSITIVE ALINITY I CMV IGG RESULTS FOR TWO PREGNANT FEMALE PATIENTS. THE FOLLOWING RESULTS WERE PROVIDED: BOTH PATIENT'S INITIAL RESULTS ON (B)(6) 2025 = NEGATIVE RESULT (NO SPECIFIC RESULT PROVIDED) (B)(6) 2025 RESULT = >200 AU/ML, SECOND RESULT >200 AU/ML CONFIRMED ON THE OTHER INSTRUMENT IN THE LABORATORY FOR TROUBLESHOOTING PURPOSES ONLY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE ALINITY I CMV IGG RESULTS 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. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT 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 70080FZ00. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER AND COMPLAINT ISSUE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. CLINICAL SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 70080FZ00, AND ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I CMV IGG ASSAY FOR LOT 70080FZ00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.