BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DETERMINE HIV-1/2 AG/AB COMBO 25T

    MDR report key: 24444079 · Received February 25, 2026

    Report

    Report Number
    1221359-2026-00024
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    August 1, 2025
    Report Date
    February 25, 2026
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP120037
    Removal / Correction Number
    1221359-07/31/2025-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5, D4: THE CUSTOMER PROVIDED THE DEVICE LOT NUMBER, BUT NOT THE KIT LOT NUMBER. BASED ON THE DEVICE LOT NUMBER, THE TEST WOULD HAVE COME FROM ONE (1) OF TWO (2) KIT LOT NUMBERS: -LOT 871699, UDI (B)(4), MANUFACTURING DATE 26APR2024, EXPIRATION DATE 28FEB2026. -LOT 867175, UDI (B)(4), MANUFACTURING DATE 19APR2024, EXPIRATION DATE 28FEB2026. INVESTIGATION FOR LOT 871699: AS PART OF AN INVESTIGATION INTO PRELIMINARY FALSE REACTIVE RESULTS, ABBOTT FOUND THAT FOR KIT LOT 871699, THE ROOT CAUSE OF THE RESULTS WAS DUE TO A SUBCOMPONENT USED IN THE MANUFACTURE OF DETERMINE HIV-1/2 AG/AG COMBO. THE ISSUE HAS BEEN ISOLATED TO SPECIFIC LOTS OF THE SUBCOMPONENT, WHICH WERE USED TO MANUFACTURE SPECIFIC TEST KIT LOTS. THE NECESSARY ACTIONS TO PREVENT RECURRENCE HAVE BEEN TAKEN, AND THE CORRECTION OF PRODUCT IN THE FIELD WAS CONDUCTED. INVESTIGATION FOR LOT 867175: THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 7D2648 / LOT: 867175, TEST BASE PART NUMBER 10732998 / LOT: 853194. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. AS PART OF AN INVESTIGATION INTO PRELIMINARY FALSE REACTIVE RESULTS, ABBOTT FOUND THAT FOR KIT LOT 867175, THE ROOT CAUSE OF THE RESULTS WAS DUE TO A SUBCOMPONENT USED IN THE MANUFACTURE OF DETERMINE HIV-1/2 AG/AG COMBO. THE ISSUE HAS BEEN ISOLATED TO SPECIFIC LOTS OF THE SUBCOMPONENT, WHICH WERE USED TO MANUFACTURE SPECIFIC TEST KIT LOTS. THE NECESSARY ACTIONS TO PREVENT RECURRENCE HAVE BEEN TAKEN, AND THE CORRECTION OF PRODUCT IN THE FIELD WAS CONDUCTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SEVEN (7) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST WITH A FINGERSTICK SAMPLE ON AN UNKNOWN DATE. THIS REPORT IS FOR TEST TWO (2) OF SEVEN (7) BETWEEN ONE (1) OF TWO (2) LOTS (871699, 867175). THE PATIENTS UNDERWENT CONFIRMATORY TESTING (METHOD UNKNOWN), WHICH RETURNED NEGATIVE RESULTS. THE PATIENTS WERE NOT ON ANTI-RETROVIRAL THERAPY AND NO MEDICATION WAS PROVIDED BASED ON THE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504552 DETERMINE HIV-1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown