BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I SYPHILIS TP REAGENT KIT

    MDR report key: 25330934 · Received May 29, 2026

    Report

    Report Number
    3002809144-2026-00139
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    May 18, 2026
    Report Date
    May 29, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LIP
    UDI-DI
    00380740162009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P60-77 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P60-21 / 31, WITH 510K NUMBER K153730.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ALINITY I SYPHILIS TP FOR A 54-YEAR-OLD MALE DIAGNOSED WITH BLOOD IN THE STOOL. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE: <1 S/CO): SID (B)(6), INITIAL SYPHILIS RESULT= 0.48 S/CO. THE RESULTS WERE QUESTIONED DUE TO HAVING A HISTORY OF A POSITIVE RESULT (UNKNOWN PLATFORM). REPEAT RESULT ON AUTOBIO PLATFORM= 1.364 S/CO (REFERENCE RANGE: <1 S/CO); TPPA RESULT= POSITIVE THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232625 ALINITY I SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ABBOTT GMBH 83345BE01 00380740162009

    Patients

    Seq Age Sex Outcome Treatment
    1