BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG REAGENT KIT

    MDR report key: 24272490 · Received February 5, 2026

    Report

    Report Number
    3002809144-2026-00025
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 17, 2026
    Report Date
    March 20, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740131265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER COMPLETE INFORMATION: SID (B)(6) = 3 DIFFERENT ALIQUOTED TUBES FROM ONE PATIENT. 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.

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I TOXO IGG DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, NO TRENDS WERE IDENTIFIED FOR LOT 76590BE00. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER. THE OVERALL PERFORMANCE OF ALINITY I TOXO IGG REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUES FOR THE COMPLAINT LOT ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I TOXO IGG REAGENT LOT 76590BE00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOXO IGG RESULTS FOR ONE SAMPLE. RESULTS WERE REPORTED TO MEDICAL PROVIDER. HISTORICAL RESULTS WERE NEGATIVE. FOLLOWING RESULTS WERE PROVIDED FROM 3 DIFFERENT ALIQUOTED TUBES: ON (B)(6) 2026, 16 YEARS OLD PREGNANT PATIENT. SID (B)(6); 16.9 IU/ML, SID (B)(6) = 34.2 IU/ML, SID (B)(6) = 0.1 IU/ML. THE CUSTOMER SUSPECTS THAT SID (B)(6) MAY BE WITH DIFFERENT PATIENT SAMPLES AND NEGATIVE RESULTS WERE GENERATED DUE TO POSSIBLE MIX UP. REFERENCE RANGE = >= 3 IU/ML POSITIVE NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I TOXO IGG RESULTS FOR ONE SAMPLE. RESULTS WERE REPORTED TO MEDICAL PROVIDER. HISTORICAL RESULTS WERE NEGATIVE. FOLLOWING RESULTS WERE PROVIDED FROM 3 DIFFERENT ALIQUOTED TUBES: (B)(6) 2026, 16 YEARS OLD PREGNANT PATIENT. SID (B)(6) =16.9 IU/ML. SID (B)(6): = 34.2 IU/ML. SID (B)(6) = 0.1 IU/ML. THE CUSTOMER SUSPECTS THAT SID (B)(6) MAY BE WITH DIFFERENT PATIENT SAMPLES AND NEGATIVE RESULTS WERE GENERATED DUE TO POSSIBLE MIX UP. REFERENCE RANGE = >= 3 IU/ML POSITIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440057 ALINITY I TOXO IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 76590BE00 00380740131265

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).