BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG REAGENT KIT

    MDR report key: 24816245 · Received April 8, 2026

    Report

    Report Number
    3002809144-2026-00089
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 8, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740131258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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/PMA/BLA NUMBER K210596. 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. ALL AVAILABLE PATIENT INFORMATION WAS PROVIDED, NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NON-REACTIVE ALINITY I TOXO IGG FOR ONE 24-YEAR-OLD MALE PATIENT DIAGNOSED WITH OCULAR TOXOPLASMOSIS ON 960 MG OF BISEPTOL STARTING ON (B)(6) 2026. THE PATIENT WAS REACTIVE BY ANOTHER METHOD. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6) ALINITY RESULT = 1.2 IU/ML ALINITY REFERENCE RANGE = <1.6 IU/ML = NEGATIVE 1.6 TO < 3.0 IU/ML = GRAY AREA = 3.0 IU/ML = POSITIVE. ROCHE RESULT = 53.8 IU/ML ROCHE REFERENCE RANGE = >3 IS POSITIVE THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876281 ALINITY I TOXO IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 81301BE00 00380740131258

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6)