BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG REAGENT KIT

    MDR report key: 24592180 · Received March 13, 2026

    Report

    Report Number
    3002809144-2026-00061
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    February 20, 2026
    Report Date
    May 15, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740131265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5 - DESCRIBE EVENT OR PROBLEM: THIS SECTION WAS UPDATED WITH ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 07P45-32 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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    UPDATE: ON 16MAR2026, THE CUSTOMER PROVIDED ADDITIONAL INFORMATION. THE PATIENT SAMPLE (SID (B)(6)) WAS SENT TO A REFERENCE LABORATORY, WHERE AN IMMUNOBLOT TESTING WAS PERFORMED AND YIELDED AN INDETERMINATE RESULT.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOXO IGG RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 30-YEAR-OLD PREGNANT FEMALE PATIENT. THESE RESULTS WERE INCONSISTENT WITH THOSE OBTAINED ON THE DIASORIN PLATFORM. THE FOLLOWING DATA WERE PROVIDED: SID: (B)(6): ON (B)(6) 2026 TOXO IGG RESULTS (B)(6) = 3.1 IU/ML (REACTIVE). OTHER RESULT PROVIDED: TOXO IGM RESULT = 0.07 INDEX (NONREACTIVE). ON (B)(6) 2026 TOXO IGG REPEAT RESULTS (B)(6) = 3.3 IU/ML (REACTIVE), 3.3 IU/ML (B)(6). SID: (B)(6) (NEW EXTRACTION): ON (B)(6) 2026 TOXO IGG RESULTS = 2.72 IU/ML (B)(6), 3.1 IU/ML (REACTIVE). OTHER RESULT PROVIDED: TOXO IGM RESULT = NONREACTIVE. ON (B)(6) 2026 DIASORIN PLATFORM: TOXO IGG = NEGATIVE. PREVIOUS RESULT ON (B)(6) 2025): TOXO IGG = NEGATIVE (DIASORIN PLATFORM). PER THE ALINITY I TOXO IGG PACKAGE INSERT, INTERPRETATION OF RESULTS SECTION: < 1.6 IU/ML = NONREACTIVE. 1.6 TO < 3.0 IU/ML = GRAYZONE. >/= 3.0 IU/ML = REACTIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346746 ALINITY I TOXO IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 79222BE00 00380740131265

    Patients

    Seq Age Sex Outcome Treatment
    1