BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HCV REAGENT KIT

    MDR report key: 25046724 · Received April 30, 2026

    Report

    Report Number
    3002809144-2026-00112
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZO
    UDI-DI
    00380740162665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P06, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P05 WITH 510K/PMA/BLA NUMBER P050042.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NON-REACTIVE ALINITY I ANTI-HCV RESULTS GENERATED FOR A 36-YEAR-OLD FEMALE PATIENT SAMPLE. THE RESULTS WERE INCONSISTENT WITH OTHER METHODS. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE ON ALL PLATFORMS <1.00 S/CO IS NONREACTIVE): SAMPLE ID (B)(6) INITIAL RESULT = 0.89 S/CO, REPEAT RESULT = 0.87 S/CO RESULT ON ROCHE PLATFORM = 27.0 S/CO, RESULT ON AUTOBIO PLATFORM = 3.3 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53798 ALINITY I ANTI-HCV REAGENT KIT ASSAY, ENZYME LINKED IMMUNOSORBENT, HEPATITIS C VIRUS MZO ABBOTT GMBH 79483BE01 00380740162665

    Patients

    Seq Age Sex Outcome Treatment
    1