BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT SYPHILIS TP

    MDR report key: 23486427 · Received November 6, 2025

    Report

    Report Number
    3002809144-2025-00353
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 22, 2025
    Report Date
    January 15, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LIP
    UDI-DI
    00380740161910
    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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8D06-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 8D06-31, WITH 510K/PMA/BLA NUMBER K153730.

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ARCHITECT SYPHILIS TP REAGENT, LOT NUMBER 72248BE01. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY ANY TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. IN-HOUSE TESTING OF A RETAINED REAGENT KIT OF THE COMPLAINT LOT WAS PERFORMED. ALL CONTROLS MET SPECIFICATIONS AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED, SHOWING THAT THE LOT GENERATES THE EXPECTED RESULTS. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ARCHITECT SYPHILIS TP REAGENT, LOT NUMBER 72248BE01.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ARCHITECT SYPHILIS TP RESULT ON A 73-YR OLD MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ABBOTT = 0.52 / 0.56 / 0.53 S/CO; ELISA, COLLOIDAL GOLD, AUTOBIO AND TPPA WERE ALL POSITIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ARCHITECT SYPHILIS TP RESULT ON A 73-YR OLD MALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ABBOTT = 0.52 / 0.56 / 0.53 S/CO; ELISA, COLLOIDAL GOLD, AUTOBIO AND TPPA WERE ALL POSITIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2637789 ARCHITECT SYPHILIS TP ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM LIP ABBOTT GMBH 72248BE01 00380740161910

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male ARC I2000SR INST, 03M74-02, (B)(6)