ALINITY I CMV IGG REAGENT KIT

Description of Event or Problem

THE CUSTOMER REPORTED FALSE REACTIVE ALINITY I CMV IGG AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2025 SAMPLE ID: (B)(6) GENERATED A RESULT OF 7.2 AU/ML (REACTIVE) THE RESULT WAS RELEASED AND QUESTIONED BY THE PATIENT'S DOCTOR. ON (B)(6) 2025, A SECOND SAMPLE WAS COLLECTED (SAMPLE ID (B)(6)), WHICH GENERATED A RESULT OF 0.9 AU/ML (NONREACTIVE). THEN BOTH SAMPLES WERE REPEATED AND GENERATED RESULTS OF 0.9 AU/ML (NONREACTIVE) PATIENT INFORMATION: 27-YEAR-OLD FEMALE PATIENT FOR PREGNANCY SCREENING. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). COMPLETE ENTRY FOR SECTION E1 - PHONE NUMBER: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P42-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33, WITH 510K/PMA/BLA NUMBER K220949. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, DEVICE HISTORY RECORD REVIEW, IN HOUSE TESTING AND LABELING REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. THE TICKET TRENDING REVIEW FOR THE ALINITY I CMV IGG REAGENT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY REGARDING COMMONALITIES FOR LOT NUMBER AND ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 70080FZ00. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND ISSUE. IN HOUSE SPECIFICITY TESTING WAS PERFORMED USING A RETAINED KIT OF ALINITY I CMV IGG REAGENT LOT 70080FZ00. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CMV IGG REAGENT LOT 70080FZ00 WAS IDENTIFIED.