BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I SYPHILIS TP REAGENT KIT

    MDR report key: 25070813 · Received May 4, 2026

    Report

    Report Number
    3002809144-2026-00116
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 4, 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. 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 07P60-31, AND A 510K NUMBER OF K153730.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY I SYPHILIS TP RESULT FOR ONE PATIENT IN THE DERMATOLOGY DEPARTMENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 0.81 S/CO, COLLOIDAL GOLD METHOD WAS POSITIVE, RESULTS FROM ROCHE =2.16 S/CO. THE CUSTOMER REFERENCE RANGE: <1.00S/CO. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221469 ALINITY I SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ABBOTT GMBH 77505BE01 00380740162009

    Patients

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