BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOXO IGG

    MDR report key: 24289821 · Received February 9, 2026

    Report

    Report Number
    3002809144-2026-00027
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 29, 2026
    Report Date
    March 24, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LGD
    UDI-DI
    00380740009212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 06C16 THAT HAS THE SAME PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06C19, 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

    THE COMPLAINT INVESTIGATION FOR A FALSE REACTIVE ARCHITECT TOXO IGG RESULT INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. TRENDING REVIEW DETERMINED NO RELATED TREND FOR THE ISSUE FOR THE PRODUCT. USING WORLDWIDE FIELD DATA GATHERED VIA FROM CUSTOMERS, THE PERFORMANCE OF REAGENT LOT 76588BE00 WAS EVALUATED AND IS PERFORMING SIMILAR TO OTHER REAGENT LOTS IN THE FIELD, CONFIRMING THERE WAS NO SYSTEMIC ISSUE. THE MEDIAN VALUE OF THE COMPLAINT LOT NUMBER IS WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO HISTORICAL REAGENT LOT PERFORMANCE. MANUFACTURING DOCUMENTATION FOR THE LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INFORMATION PROVIDED AND ABBOTT DIAGNOSTICS¿ COMPLAINT INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT TOXO IGG REAGENT, LOT NUMBER 76588BE00, WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE REACTIVE ARCHITECT TOXO IGG RESULT GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULES FOR A 36-YEAR-OLD FEMALE PATIENT. THE SAMPLE WAS REPEATED ON ANOTHER ARCHITECT INSTRUMENT AND YIELDED A NONREACTIVE RESULT. THE FOLLOWING DATA WERE PROVIDED: SID (B)(6): ON (B)(6) 2026 INITIAL RESULT = 89 IU/ML (B)(6), REPEAT RESULT (DIFFERENT INSTRUMENT) = NONREACTIVE. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE REACTIVE ARCHITECT TOXO IGG RESULT GENERATED BY THE ARCHITECT I2000SR PROCESSING MODULES FOR A 36-YEAR-OLD FEMALE PATIENT. THE SAMPLE WAS REPEATED ON ANOTHER ARCHITECT INSTRUMENT AND YIELDED A NONREACTIVE RESULT. THE FOLLOWING DATA WERE PROVIDED: SID (B)(6): (B)(6) 2026 INITIAL RESULT = 89 IU/ML (B)(6), REPEAT RESULT (DIFFERENT INSTRUMENT) = NONREACTIVE. 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
    354873 ARCHITECT TOXO IGG ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ABBOTT GMBH 76588BE00 00380740009212

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female ARC I2000SR INST, 03M74-02, (B)(6).| ARC I2000SR INST, 03M74-02, (B)(6).