BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23482468 · Received November 5, 2025

    Report

    Report Number
    1221359-2025-00816
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    April 3, 2025
    Report Date
    November 5, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    MZF
    UDI-DI
    00811877011101
    PMA / PMN Number
    BP120037
    Removal / Correction Number
    1221359-07/31/2025-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - IT WAS NOT SPECIFIED WHEN THE PATIENT TOOK THE TEST, HOWEVER, THE COMPLAINANT PROVIDED TWO DATES ((B)(6) 2025 AND (B)(6) 2025) WHEN THE PATIENT TOOK THE TEST. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 834146 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SAMPLES. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 7D2648 / LOT 834146, DEVICE PART NUMBER 10732998 / LOT 834824. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 834146 SHOWED THAT THE COMPLAINT RATE IS (B)(4). AS PART OF AN INVESTIGATION INTO PRELIMINARY FALSE REACTIVE RESULTS, ABBOTT FOUND THAT FOR KIT LOT 834146, 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 TWO (2) PATIENTS WHO RECEIVED FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST TAKEN ON VARIOUS DATES WITH A WHOLE BLOOD SAMPLE. THIS REPORT IS FOR PATIENT TWO (2) OF TWO (2). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST TAKEN ON EITHER (B)(6) 2025 OR (B)(6) 2025. A CONFIRMATORY TEST (METHOD AND BRAND UNKNOWN) WAS TAKEN WHICH RETURNED NEGATIVE RESULTS. THE PATIENT WAS NOT ON ART AND WAS UNDERGOING A SCREENING PROCESS TO GET PRE-EXPOSURE PROPHYLAXIS. THE CUSTOMER REPORTED NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2678350 DETERMINE HIV-1/2 AG/AB COMBO 25T TEST, HIV DETECTION MZF ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 834146 00811877011101

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male