BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HIV AG/AB COMBO

    MDR report key: 24734447 · Received March 30, 2026

    Report

    Report Number
    3002809144-2026-00075
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 15, 2026
    Report Date
    March 30, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZF
    UDI-DI
    00380740112592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MK
    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 04J27 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02P36, HIV AG/AB COMBO, WITH BLA NUMBER BP090080.

    Description of Event or Problem · 0

    A CONFERENCE ABSTRACT BY MAKAROVSKA BOJADJIEVA, T., NIKOLOSKA, ET AL., ¿THE YIELD OF NUCLEIC ACID TESTING A THREE YEARS EXPERIENCE¿, VOX SANGUINIS. 2025; 120316, NOTED FALSE NEGATIVE ARCHITECT HIV AG/AB COMBO RESULTS GENERATED ON THE ARCHITECT (B)(4). THE STUDY STATED THAT DONOR BLOOD SAMPLES WERE SCREENED FOR THE PRESENCE ANTI-HIV/P24 USING THE ARCHITECT I2000SR PLATFORM. THE DATA SHOWED 1 DONOR SAMPLE WAS HIV DNA POSITIVE / ANTI-HIVP24 NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785725 ARCHITECT HIV AG/AB COMBO TEST, HIV DETECTION MZF ABBOTT GMBH 00380740112592

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, (B)(6).