BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOXO IGG

    MDR report key: 24640177 · Received March 19, 2026

    Report

    Report Number
    3002809144-2026-00067
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 25, 2026
    Report Date
    May 15, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740009212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 06C19-35 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06C19, WITH 510K NUMBER K210596.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT TOXO IGG FOR A 30-YEAR-OLD PREGNANT FEMALE. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2026, SID (B)(6), INITIAL TOXO IGG RESULT= 10.9 IU/ML (POSITIVE); REPEAT RESULT= 0.0 IU/ML. (B)(6) 2025, SID (B)(6), HISTORICAL RESULT= 0.0 IU/ML WITH A REPEAT RESULT= 0.0 IU/ML. THE IGM WAS NEGATIVE IN BOTH SAMPLES. SAMPLES WERE TESTED AT A REFERENCE LAB WITH NEGATIVE RESULTS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150469 ARCHITECT TOXO IGG ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 81300BE00 00380740009212

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female ARC I2SR REFURB-SEKAT, 03M74-97, (B)(6)