BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG REAGENT KIT

    MDR report key: 24747380 · Received March 31, 2026

    Report

    Report Number
    3002809144-2026-00081
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740131258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P45-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P45-40 / 45, WITH 510K NUMBER K210596.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I TOXO IGG FOR A 29-YEAR-OLD PREGNANT FEMALE. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6), INITIAL TOXO IGG RESULT= 52.31 IU/ML (POSITIVE). THE PHYSICIAN REQUESTED THE SAMPLE TO BE RETESTED AS IT DID NOT MATCH THE PATIENT¿S CLINICAL PRESENTATION. REPEAT RESULTS= 0.03 IU/ML, 0.02 IU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83883 ALINITY I TOXO IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 76589BE00 00380740131258

    Patients

    Seq Age Sex Outcome Treatment
    1