BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG REAGENT KIT

    MDR report key: 24507340 · Received March 4, 2026

    Report

    Report Number
    3002809144-2026-00052
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 10, 2026
    Report Date
    May 15, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740131258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P45-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P45-40, AND A 510K/PMA/BLA NUMBER OF K210596.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY I TOXO IGG RESULTS GENERATED FOR A 37-YEAR-OLD FEMALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6), INITIAL RESULT = 3.1 IU/ML, REPEAT RESULTS = 3.4 IU/ML, 2.9 IU/ML, 2.9 IU/ML, 3.0 IU/ML ADDITIONAL DATA WAS PROVIDED: TOXO IGM RESULT = 0.06 INDEX (NON-REACTIVE) SAMPLE WAS SENT TO THE REFERENCE LABORATORY: TOXO IGG ON ELISA AND ELFA PLATFORMS = NEGATIVE TOXO IGM ON ELISA PLATFORM = NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315121 ALINITY I TOXO IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 73692BE00 00380740131258

    Patients

    Seq Age Sex Outcome Treatment
    1