BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBC II

    MDR report key: 25187186 · Received May 15, 2026

    Report

    Report Number
    3002809144-2026-00125
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 15, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOM
    UDI-DI
    00380740162610
    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 FOLLOW-UP 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 08L44 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6L22, WITH PMA NUMBER P080023.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ARCHITECT ANTI-HBC II FOR A 65-YEAR-OLD MALE. THE PATIENT WAS ON DIALYSIS AND RECEIVING ANTI-VIRAL TREATMENT FOR HEPATITIS B. THE FOLLOWING INFORMATION WAS PROVIDED: INITIAL ANTI-HBC RESULT= NEGATIVE; REPEAT RESULTS PERFORMED ON YHLO PLATFORM WITH A DIFFERENT SAMPLE AT A LATER DATE= POSITIVE. ADDITIONAL RESULTS PROVIDED: HBSAG RESULT= POSITIVE; ALL OTHER HEPATITIS RESULTS= NEGATIVE; NAT RESULT= POSITIVE HBSAG RESULT ON YHLO PLATFORM WITH A DIFFERENT SAMPLE COLLECTED AT A LATER DATE= POSITIVE; ALL OTHER HEPATITIS RESULTS WERE NEGATIVE THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562295 ARCHITECT ANTI-HBC II TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT GMBH 80183BE01 00380740162610

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male ARC I2000SR INST, 03M74-02, (B)(6)