BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I TOXO IGG REAGENT KIT

    MDR report key: 22884131 · Received August 25, 2025

    Report

    Report Number
    3002809144-2025-00273
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    July 29, 2025
    Report Date
    October 23, 2025
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740131265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 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.

    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 DATA FOR THE ALINITY I TOXO IGG ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINTS RELATED TO THE ISSUE UNDER REVIEW. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR THE REAGENT LOT. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. RETAINED KIT OF THE ALINITY I TOXO IGG REAGENT LOT NUMBER 73692BE00 WAS CALIBRATED AND THE CALIBRATION MET INSTRUMENT SPECIFICATIONS. ALL CONTROL VALUES MET CONTROL SPECIFICATIONS AND WERE IN THE TYPICAL RANGE. TO EVALUATE REAGENT PERFORMANCE, 3 ADDITIONAL REPLICATES OF POSITIVE CONTROL 1 WERE TESTED WITH ALINITY I TOXO IGG REAGENT LOT. ALL POSITIVE CONTROL 1 VALUES MET SPECIFICATIONS, AND THE RESULTS WERE IN THE TYPICAL RANGE AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED. TESTING INCLUDED ONE SEROCONVERSION PANEL ID 461957152. THE ALINITY I TOXO IGG COMPLAINT LOT NUMBERS DETECTED THE SAME BLEEDS AS REACTIVE WITH COMPARABLE S/CO VALUES AS HISTORICAL PERFORMANCE SHOWN BY COMPARISON DATA LISTED IN THE INSTRUCTIONS FOR USE. NOTE: POSITIVE CONTROL 2 IS A HIGH TITER CONTROL WHICH IS NOT RELEVANT FOR SENSITIVITY RELATED COMPLAINTS AND THEREFORE NOT INCLUDED IN THE TESTING SETUP. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I TOXO IGG ASSAY WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TOXO IGG RESULTS FOR ONE PREGNANT FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2025 SID (B)(6) ALINITY I TOXO IGG 1.5 (NEGATIVE) LOT 73693BE00. THE SAMPLE TESTED POSITIVE IN ANOTHER LAB WITH TITER OF 1:64. FROM ANOTHER PRIVATE LABORATORY: TOXO IGG: 1:16; TOXO IGM NEGATIVE, FROM THE AKH VIENNA TOXOPLASMOSIS LABORATORY: FROM 23JUL2025 TOXO IGG 1:64; TOXO IGM NEGATIVE, SYNLAB RESULT FROM (B)(6) 2025 TOXO IGG 1.2 IU/ML; TOXO IGM NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I TOXO IGG RESULTS FOR ONE PREGNANT FEMALE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: ON (B)(6) 2025, SID (B)(6), ALINITY I TOXO IGG 1.5 (NEGATIVE) LOT 73693BE00 THE SAMPLE TESTED POSITIVE IN ANOTHER LAB WITH TITER OF 1:64. FROM ANOTHER PRIVATE LABORATORY: TOXO IGG: 1:16; TOXO IGM NEGATIVE, FROM THE AKH VIENNA TOXOPLASMOSIS LABORATORY: FROM (B)(6) 2025 TOXO IGG 1:64; TOXO IGM NEGATIVE, SYNLAB RESULT FROM (B)(6) 2025 TOXO IGG 1.2 IU/ML: TOXO IGM NEGATIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335582 ALINITY I TOXO IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 73693BE00 00380740131265

    Patients

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