BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I SYPHILIS TP REAGENT KIT

    MDR report key: 24703085 · Received March 26, 2026

    Report

    Report Number
    3002809144-2026-00074
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    March 17, 2026
    Report Date
    May 19, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LIP
    UDI-DI
    00380740121648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 07P60-22 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 LITERATURE ARTICLE PUBLISHED IN THE INTERNATIONAL JOURNAL OF STD & AIDS, 2026, VOL 37, TITLED ¿THE END OF THE GOLD STANDARD IN SYPHILIS DIAGNOSTICS - A COMPARISON OF ALTERNATIVE SCREENING TEST METHODS¿ BY FAZIO ET.AL. NOTED FALSE NEGATIVE ALINITY I SYPHILIS RESULTS FOR THREE PATIENTS WHEN COMPARED TO OTHER METHODS. ALL THREE SAMPLES HAD A POSITIVE TPPA TITER AND CONTAIN TREPONEMA-SPECIFIC ANTI BODIES WITH NEGATIVE LIPOID ANTIBODY FINDINGS. BASED ON THE FINDINGS AND AVAILABLE INFORMATION (TIME OF INFECTION AND LACK OF SYMPTOMS), PATIENT 1 IS ASSIGNABLE TO THE EARLY LATENT STAGE. PATIENT 2 EXHIBITED A GENITAL SYPHILITIC LESION AT THE TIME OF BLOOD SAMPLING, INDICATING AN ACTIVE AND INFECTIOUS STAGE. FOR PATIENT 3 THE ANAMNESTIC INFORMATION INDICATED THE RESULTS TO BE A RESIDUAL FINDING FOLLOWING A PREVIOUSLY TREATED TREPONEMA INFECTION. PATIENT 1 ALINITY I SYPHILIS 0.75 INDEX, TPPA TITER 1:80, IGG-FTA-ABS TITER 1:10 (WEAKLY POSITIVE), I9S-IGM-FTA-ABS TITER 1:40, RPR NEGATIVE, EIA 11.08 RE/ML (<16-22 RE/ML IS NEGATIVE), ECLIA 0.350 COI (<1.0 COI IS NONREACTIVE), CLIA 1.4 INDEX (<1.1 IS NONREACTIVE). PATIENT 2 ALINITY I SYPHILIS 0.52 INDEX, TPPA TITER 1:640, IGG-FTA-ABS TITER 1:20 (POSITIVE), I9S-IGM-FTA-ABS TITER 1:80, RPR NEGATIVE, EIA 9.73 RE/ML (<16-22 RE/ML IS NEGATIVE), ECLIA 0.583 COI (<1.0 COI IS NONREACTIVE), CLIA 2.0 INDEX (<1.1 IS NONREACTIVE). PATIENT 3 ALINITY I SYPHILIS 0.42 INDEX, TPPA TITER 1:80, IGG-FTA-ABS TITER 1:5 (BORDERLINE), I9S-IGM-FTA-ABS TITER 1:160, RPR NEGATIVE, EIA 7.85 RE/ML (<16-22 RE/ML IS NEGATIVE), ECLIA 1.760 COI (<1.0 COI IS NONREACTIVE), CLIA 0.7 INDEX (<1.1 IS NONREACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425406 ALINITY I SYPHILIS TP REAGENT KIT ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ABBOTT GMBH 00380740121648

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, UNKNOWNGERMANY