BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HIV AG/AB COMBO REAGENT KIT

    MDR report key: 23744765 · Received December 8, 2025

    Report

    Report Number
    3002809144-2025-00386
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 26, 2025
    Report Date
    January 19, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZF
    UDI-DI
    00380740196592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P07-84 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT EVALUATION FOR FALSE NON-REACTIVE ALINITY I HIV AG/AB COMBO RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I HIV AG/AB COMBO ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 76321BE00. THE DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE, OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER. IN-HOUSE SENSITIVITY TESTING OF A RETAINED REAGENT KIT OF COMPLAINT LOT 76321BE00 WAS PERFORMED. ALL SPECIFICATIONS WERE MET AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED, SHOWING THAT THE LOT GENERATES THE EXPECTED RESULTS. IN ADDITION, THE CLINICAL SENSITIVITY OF THE LOT WAS EVALUATED BY TESTING ONE COMMERCIALLY AVAILABLE SEROCONVERSION PANEL (ZEPTOMETRIX HIV 9016). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO ARCHITECT HIV AG/AB COMBO TEST RESULTS (ALINITY I HIV AG/AB COMBO IS EQUIVALENT TO ARCHITECT HIV AG/AB COMBO AS THEY SHARE THE SAME BULK REAGENTS) PROVIDED BY ZEPTOMETRIX AND THE REAGENT LOT DETECTED THE SAME BLEEDS AS REACTIVE. BASED ON THESE DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE OF THE COMPLAINT LOT IS NOT ADVERSELY AFFECTED. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I HIV AG/AB COMBO FOR LOT NUMBER 76321BE00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NEGATIVE ALINITY I HIV AG/AB COMBO RESULTS FOR A 72-YEAR-OLD MALE PATIENT IN THE DERMATOLOGY AND VENEREAL DISEASES CLINIC. THE PATIENT HAS BEEN DIAGNOSED WITH LATENT SYPHILIS AND HAD BEEN HIV-POSITIVE FOR MANY YEARS, CONSISTENTLY TAKING MEDICATION. ALINITY RESULTS WITH SID (B)(6) = 0.55 S/CO AND SID (B)(6) = 0.51 S/CO ELISA RESULT = 5.047 S/CO POSITIVE, COLLOIDAL GOLD RESULT = WEAK POSITIVE (NO SPECIFIC RESULT PROVIDED) PATIENT HISTORICAL ELISA RESULTS: (B)(6) 2025 = 13.966 S/CO, (B)(6) 2025 RESULT = 12.309 S/CO, (B)(6) 2025 = 17.181 S/CO NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NEGATIVE ALINITY I HIV AG/AB COMBO RESULTS FOR A 72-YEAR-OLD MALE PATIENT IN THE DERMATOLOGY AND VENEREAL DISEASES CLINIC. THE PATIENT HAS BEEN DIAGNOSED WITH LATENT SYPHILIS AND HAD BEEN HIV-POSITIVE FOR MANY YEARS, CONSISTENTLY TAKING MEDICATION. ALINITY RESULTS WITH SID (B)(6) = 0.55 S/CO AND SID (B)(6) = 0.51 S/CO. ELISA RESULT = 5.047 S/CO POSITIVE, COLLOIDAL GOLD RESULT = WEAK POSITIVE. (NO SPECIFIC RESULT PROVIDED) PATIENT HISTORICAL ELISA RESULTS: (B)(6) 2025 = 13.966 S/CO, (B)(6) 2025 RESULT = 12.309 S/CO, (B)(6) 2025 = 17.181 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157447 ALINITY I HIV AG/AB COMBO REAGENT KIT TEST, HIV DETECTION MZF ABBOTT GMBH 76321BE00 00380740196592

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6).