BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-TPO REAGENT KIT

    MDR report key: 23767977 · Received December 10, 2025

    Report

    Report Number
    3008344661-2025-00176
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 26, 2025
    Report Date
    February 19, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    JZO
    UDI-DI
    00380740150617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. A1 - PATIENT IDENTIFIER: (B)(6) (COMPLETE SAMPLE ID). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 09P35-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 09P35-21, WITH 510K/PMA/BLA NUMBER K052407. SEE MFR REPORT 3008344661-2025-00175 FOR SUBMISSION ON ALINITY I ANTI-TPO, REAGENT LOT 65479FZ00.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION IN SECTION H6: MEDICAL DEVICE PROBLEM CODE. THE COMPLAINT INVESTIGATION FOR IMPRECISE ALINITY I ANTI-TPO RESULTS 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. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I ANTI-TPO ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 77546FZ00 AND SUBLOT 77546FZ. THE DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE, OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER AND COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF ALINITY I ANTI-TPO REAGENT WAS REVIEWED USING WORLDWIDE FIELD DATA. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT AND INDICATED THAT THE PATIENT MEDIAN RESULT FOR LOT 77546FZ00 WAS WITHIN THE ESTABLISHED CONTROL LIMITS. THEREFORE, NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I ANTI-TPO FOR LOT NUMBER 77546FZ00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED IMPRECISE ALINITY I ANTI-TPO RESULTS FOR A 32-YEAR-OLD FEMALE GENERATED ON THE ALINITY I PROCESSING MODULE. THE PATIENT IN QUESTION HAD NO CLINICAL INFORMATION ON THE TESTING REQUESTED, HOWEVER IN (B)(6) 2023 HAD AN ANTI-TPO RESULT OF 0.24 IU/ML. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: < 5.61 IU/ML): SID (B)(6) PRESENTED THE FOLLOWING ANTI-TPO RESULTS: ON (B)(6) (USING REAGENT LOT 65479FZ00): 14.44 EXPC / 0.62 EXPC / 7.09 EXPC / 2.51 EXPC (EXPC FLAG REFERS TO AN EXPIRED CALIBRATION CURVE) IT WAS NOTED THE CONTROLS WERE WITHIN THE REFERENCE RANGE. ON (B)(6), THE CUSTOMER ONLY PASSED LEVEL 2 OF QC, AND THE VALUE WAS 45.99 IU/ML FOR TECHNOPATH QC ON (B)(6): 7.97 / 2.55 / 1.98 IU/ML ON (B)(6) AFTER CHANGING THE REAGENT LOT AND CALIBRATING THE ANTI-TPO REAGENT LOT 77546FZ00 THE FOLLOWING RESULTS WERE OBTAINED: 5.78 / 3.35 / 2.27 IU/ML. IT IS UNCLEAR WHICH RESULTS CORRELATE TO THE PATIENT'S CLINICAL PICTURE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED IMPRECISE ALINITY I ANTI-TPO RESULTS FOR A 32-YEAR-OLD FEMALE GENERATED ON THE ALINITY I PROCESSING MODULE. THE PATIENT IN QUESTION HAD NO CLINICAL INFORMATION ON THE TESTING REQUESTED, HOWEVER IN DECEMBER 2023 HAD AN ANTI-TPO RESULT OF 0.24 IU/ML. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE: < 5.61 IU/ML): SID (B)(6) PRESENTED THE FOLLOWING ANTI-TPO RESULTS: ON (B)(6) (USING REAGENT LOT 65479FZ00): 14.44 EXPC / 0.62 EXPC / 7.09 EXPC / 2.51 EXPC (EXPC FLAG REFERS TO AN EXPIRED CALIBRATION CURVE) IT WAS NOTED THE CONTROLS WERE WITHIN THE REFERENCE RANGE. ON (B)(6), THE CUSTOMER ONLY PASSED LEVEL 2 OF QC, AND THE VALUE WAS 45.99 IU/ML FOR TECHNOPATH QC. ON (B)(6): 7.97 / 2.55 / 1.98 IU/ML ON (B)(6) AFTER CHANGING THE REAGENT LOT AND CALIBRATING THE ANTI-TPO REAGENT LOT 77546FZ00 THE FOLLOWING RESULTS WERE OBTAINED: 5.78 / 3.35 / 2.27 IU/ML. IT IS UNCLEAR WHICH RESULTS CORRELATE TO THE PATIENT'S CLINICAL PICTURE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218225 ALINITY I ANTI-TPO REAGENT KIT SYSTEM, TEST, THYROID AUTOANTIBODY JZO ABBOTT IRELAND DIAGNOSTICS DIVISION 77546FZ00 00380740150617

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).