BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HIV AG/AB COMBO REAGENT KIT

    MDR report key: 24346217 · Received February 16, 2026

    Report

    Report Number
    3002809144-2026-00041
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    February 2, 2026
    Report Date
    April 10, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    MZF
    UDI-DI
    00380740121785
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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.

    Additional Manufacturer Narrative · 0

    REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I HIV AG/AB COMBO REAGENT 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 82125BE00. A REVIEW OF THE CORRECTIVE AND PREVENTIVE ACTIONS SYSTEM DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF COMPLAINT LOT 82125BE00 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. THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO ARCHITECT HIV AG/AB COMBO TEST RESULTS AND THE REAGENT LOT DETECTED THE SAME BLEEDS AS REACTIVE. (NOTE: ALINITY I HIV AG/AB COMBO IS EQUIVALENT TO ARCHITECT HIV AG/AB COMBO AS THEY SHARE THE SAME BULK REAGENTS.) BASED ON THESE DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE OF THE COMPLAINT LOT IS NOT ADVERSELY AFFECTED. LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY OF THE ALINITY I HIV AG/AB COMBO REAGENT LOT 82125BE00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY I HIV AG/AB RESULT FOR A KNOWN HIV POSITIVE PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2026, SID (B)(6): INITIAL RESULT = 0.06 S/CO, REPEAT WITH SERUM BANK TUBE ON (B)(6) 2026 = 12.87 S/CO NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY I HIV AG/AB RESULT FOR A KNOWN HIV POSITIVE PATIENT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2026, SID (B)(6): INITIAL RESULT = 0.06 S/CO, REPEAT WITH SERUM BANK TUBE ON (B)(6) 2026 = 12.87 S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466722 ALINITY I HIV AG/AB COMBO REAGENT KIT TEST, HIV DETECTION MZF ABBOTT GMBH 82125BE00 00380740121785

    Patients

    Seq Age Sex Outcome Treatment
    1