BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGM REAGENT KIT

    MDR report key: 24960307 · Received April 22, 2026

    Report

    Report Number
    3002809144-2026-00103
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    February 16, 2026
    Report Date
    April 22, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740130954
    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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P47-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P47-40, WITH 510K/PMA/BLA NUMBER K233932.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I TOXO IGM RESULTS GENERATED FOR ONE 30-YEAR-OLD PREGNANT FEMALE. THE FOLLOWING DATA WAS PROVIDED (PACKAGE INSERT REFERENCE RANGE >/= 0.60 INDEX IS REACTIVE): SID (B)(6), PROCESSED ON (B)(6) 2026 ALINITY I TOXO IGM RESULT = 1.24 TOXO IGG RESULT = 0.40 SID (B)(6), PROCESSED ON (B)(6) 2026 ALINITY I TOXO IGM RESULT = 1.20 TOXO IGG RESULT = 0.30. ECLIA METHOD TOXO IGM = NEGATIVE 0.18(<0.80 IS NEGATIVE) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545392 ALINITY I TOXO IGM REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 78427BE00 00380740130954

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6)