BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HIV AG/AB COMBO REAGENT KIT

    MDR report key: 23959541 · Received January 5, 2026

    Report

    Report Number
    3002809144-2026-00002
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 25, 2025
    Report Date
    February 23, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZF
    UDI-DI
    00380740196608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 ANY TRENDS RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, NO TRENDS WERE IDENTIFIED FOR LOT 77618BE00. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF COMPLAINT LOT 77618BE00 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 THE ARCHITECT HIV AG/AB COMBO TEST RESULTS PROVIDED BY ZEPTOMETRIX AND THE REAGENT LOT DETECTED THE SAME BLEEDS AS REACTIVE. THE ARCHITECT HIV AG/AB COMBO CONTAINS THE SAME BULK MATERIALS AS THE ALINITY I HIV AG/AB COMBO. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I HIV AG/AB COMBO REAGENT LOT 77618BE00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P07 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8P07-21/31, AND 510K/PMA/BLA OF P090080. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED NEGATIVE ALINITY I HIV AG/AB COMBO RESULTS. SID (B)(6) TESTED ALINITY I HIV AG/AB COMBO NEGATIVE OF 0.19, 0.20 S/CO BUT REPEATED AUTOBIO POSITIVE OF 7.93 S/CO, AND ELISA COLLOIDAL GOLD POSITIVE. THE PATIENT IS A 26 YEAR-OLD FEMALE WITH CLINICAL DIAGNOSIS OF CHRONIC PELVIC INFLAMMATORY DISEASE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED NEGATIVE ALINITY I HIV AG/AB COMBO RESULTS. SID (B)(6) TESTED ALINITY I HIV AG/AB COMBO NEGATIVE OF 0.19, 0.20 S/CO BUT REPEATED AUTOBIO POSITIVE OF 7.93 S/CO, AND ELISA COLLOIDAL GOLD POSITIVE. THE PATIENT IS A 26-YEAR-OLD FEMALE WITH CLINICAL DIAGNOSIS OF CHRONIC PELVIC INFLAMMATORY DISEASE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283358 ALINITY I HIV AG/AB COMBO REAGENT KIT TEST, HIV DETECTION MZF ABBOTT GMBH 77618BE00 00380740196608

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).