BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG REAGENT KIT

    MDR report key: 24764368 · Received April 2, 2026

    Report

    Report Number
    3002809144-2026-00083
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 2, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740131258
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER:(B)(6). 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 7P45-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P45-40 / 45, WITH 510K/PMA/BLA NUMBER K210596.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOXO IGG FOR ONE PREGNANT FEMALE PATIENT. THE PATIENT HAS A HISTORY OF BEING TOXO IGG NEATIVE. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2026, SID (B)(6), INITIAL TOXO IGG RESULT= 21.8 IU/ML (REACTIVE); ADDITIONAL RESULT PROVIDED, TOXO IGM= 0.08 INDEX (NONREACTIVE) (B)(6) 2026, SAMPLE WAS REPEAT WITH TOXO IGG RESULTS= 0.1 IU/ML AND TOXO IGM RESULT= 0.9 IU/ML; ANOTHER SAMPLE TUBE DRAWN ON (B)(6) 2026 WAS TESTED WITH TOXO IGG RESULT= 0.1 IU/ML AND TOXO IGM RESULT= 0.09 INDEX. A SAMPLE FROM (B)(6) 2026 WAS RETESTED WITH A TOXO IGG RESULT= 0.1 IU/ML; AND TOXO IGM RESULT= 0.08 INDEX. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830946 ALINITY I TOXO IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 81301BE00 00380740131258

    Patients

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