BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I SYPHILIS TP REAGENT KIT

    MDR report key: 24629316 · Received March 18, 2026

    Report

    Report Number
    3002809144-2026-00064
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    March 9, 2026
    Report Date
    May 7, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LIP
    UDI-DI
    00380740161927
    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 A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P60-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P60-21 / 31, WITH 510K/PMA/BLA NUMBER K153730. 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 REPORTED A FALSE NONREACTIVE ALINITY I SYPHILIS TP RESULT FOR A 34-YEAR-OLD MALE PATIENT. THE RESULT WAS INCONSISTENT WITH THOSE OBTAINED USING OTHER METHODS. THE FOLLOWING DATA WAS PROVIDED (1.00 S/CO IS NONREACTIVE, = 1.00 S/CO IS REACTIVE): SID (B)(6): (B)(6) 2026 ALINITY I SYPHILIS TP RESULT = 0.09 S/CO (NONREACTIVE) ELISA RESULT = 17.328 S/CO (POSITIVE) TPPA RESULT = WEAK POSITIVE. RPR RESULT = NEGATIVE . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370530 ALINITY I SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ABBOTT GMBH 76538BE01 00380740161927

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female ALNTY I PROCESSING MODU, 03R65-01, AI05166