BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB-IGG

    MDR report key: 25124498 · Received May 8, 2026

    Report

    Report Number
    3002809144-2026-00120
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 8, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOL
    UDI-DI
    00380740115319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 6C29 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6L27, WITH 510K/PMA/BLA NUMBER K113704.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT HAVAB-IGG RESULTS FOR ONE PATIENT. THE RESULTS DID NOT MATCH PATIENT HISTORY. THE FOLLOWING DATA WAS PROVIDED: SID INITIAL RESULT = 1.21 REPEAT RESULT = 1.27 S/CO NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424619 ARCHITECT HAVAB-IGG HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY) LOL ABBOTT GMBH 81411BE00 00380740115319

    Patients

    Seq Age Sex Outcome Treatment
    1