BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HIV AG/AB COMBO REAGENT KIT

    MDR report key: 24815932 · Received April 8, 2026

    Report

    Report Number
    3002809144-2026-00088
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 8, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZF
    UDI-DI
    00380740121785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P07-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P07-21 / 31 , WITH 510K/PMA/BLA NUMBER P090080. 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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NEGATIVE ARCHITECT HIV AG/AB RESULTS GENERATED FOR A KNOWN HIV-POSITIVE FEMALE PATIENT (FIRST SCREENING REACTIVE IN 2023). THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE <1.0 S/CO IS NON-REACTIVE): SID (B)(6) ABBOTT ALINITY RESULT FROM (B)(6) 2026 = 0.91 REPEAT RESULTS = 0.91 AND 0.87 S/CO REPEATED AGAIN = 0.729 S/CO. HIV-DUO (P-24 + A-HIV-IGG) RAW VALUE 0.91 NEGATIVE: REACTIVE 458.00. CONFIRMATORY TESTING REFERENCE LAB RESULTS: EDTA PLASMA HIV-1/2 ANTIBODIES, LIA QL HIV-1 POSITIVE WESTERN BLOT: HIV-1 SGP 120 0, HIV-1 GP41 2, HIV P31 0, HIV P24 1, HIV P17 0, HIV-2 SGP105 0, HIV-2 GP36 0. REFERENCE LAB RAN ANOTHER CONFIRMATION BLOT TEST (MANUFACTURED BY FUJIREBIO) AGAIN AND CONFIRMED THE RESULT. THE BANDS WERE SEMI-QUANTITATIVELY EVALUATED (WITH 1,2,3). GP41 IS CLEAR AND P24 WEAKLY DETECTABLE. HISTORICAL RESULTS FROM (B)(6) 2025: WESTERN BLOT WAS POSITIVE FOR ANTIGEN ONLY NEGATIVE FOR ANTIBODIES. RAPID TEST = NEGATIVE ABBOTT ALINITY = NEGATIVE. ADDITIONAL DATA PROVIDED 27MAR2026: THE CUSTOMER REPEATED THE SAMPLE FROM (B)(6) 2026 WITH HETEROPHILIC BLOCKING TUBE RESULT = 0.84 RESULT WITHOUT HBT = 0.83 THE RESULTS ARE CLINICALLY THE SAME. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90600 ALINITY I HIV AG/AB COMBO REAGENT KIT TEST, HIV DETECTION MZF ABBOTT GMBH 80393BE00 00380740121785

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6)