BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY M EBV AMP KIT

    MDR report key: 24121824 · Received January 20, 2026

    Report

    Report Number
    3005248192-2026-00009
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    October 16, 2025
    Report Date
    January 28, 2026
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    QLX
    UDI-DI
    00884999049505
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS COMPLAINT INCLUDED A CUSTOMER DATA REVIEW, A QUALITY DATA REVIEW, AND A COMPLAINT HISTORY REVIEW INVESTIGATION IS SUMMARIZED AS FOLLOWS: CUSTOMER DATA REVIEW CUSTOMER RESULT LOG FILES WERE REVIEWED. THE ALINITY M EBV CONTROLS WERE VALID, ESTABLISHING THE VALIDITY OF THE RUNS INVOLVING THE REPORTED SAMPLE. THEREFORE, ALINITY M EBV WB APPLICATION SPECIFICATION FILE (LIST 09N43-9A) AND THE ALINITY M EBV APPLICATION SPECIFICATION FILE (LIST 09N43-7B) ARE PERFORMING AS EXPECTED. THE VALIDITY OF THE RUNS ASSOCIATED WITH REPORTED SAMPLES WAS VERIFIED. THE AMPLIFICATION CURVES PRODUCED THE EXPECTED SIGNAL PATTERNS FOR BOTH POSITIVE AND NEGATIVE SAMPLES ON THE WHOLE BLOOD AND PLASMA ASSAYS. ALL RESULTS SHOULD BE REVIEWED IN CONJUNCTION WITH OTHER CLINICAL DATA BEFORE ANY PATIENT MANAGEMENT DECISIONS ARE MADE, AND IF THERE IS ANY INCONSISTENCY, ADDITIONAL TESTING IS RECOMMENDED. QUALITY DATA REVIEW CAPA / NON-CONFORMANCE REVIEW: A PART AND KEYWORD SPECIFIC SEARCH WERE PERFORMED TO IDENTIFY RELATED EXISTING INTERNAL QUALITY RECORDS WHICH COULD RESULT IN THE REPORTED COMPLAINT AND PART NUMBER. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED BY THIS REVIEW. COMPLAINT HISTORY REVIEW THE PART AND KEYWORD SPECIFIC SEARCH PERFORMED DID NOT IDENTIFY ANY ADDITIONAL RELATED ELEVATED COMPLAINTS. COMPLAINT TRENDING WAS COMPLETED. A TREND VIOLATION WAS NOT IDENTIFIED, AND THE UPPER CONTROL LIMIT WAS NOT EXCEEDED FOR PART 09N43 (TRENDING PART NUMBER). NO ADVERSE TREND WAS IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION ELEMENTS, A PRODUCT DEFICIENCY FOR ALINITY M EBV WB APPLICATION SPECIFICATION FILE (LIST 09N43-9A) AND THE ALINITY M EBV APPLICATION SPECIFICATION FILE (LIST 09N43-7B) WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED INTERNATIONALLY USING THE ALINITY M EBV ASSAY, LIST NUMBER 09N43-091, WHICH IS THE SAME/SIMILAR TO THE ALINITY M EBV ASSAY, LIST NUMBER 09N43-095 , WHICH RECEIVED FDA APPROVAL.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NOT DETECTED RESULTS ON THE ALINITY M EBV AMP KIT. THE CUSTOMER REPORTED 1 PATIENT HAD 2 FALSE NOT DETECTED RESULTS: SAMPLE ID (SID) (B)(6) WAS "NOT DETECTED" FOR EBV-PLASMA PROTOCOL ON (B)(6) 2025. IN ADDITION SID (B)(6) (VIRAL LOAD OF 1479 IU/ML FOR WHOLE BLOOD) WAS "NOT DETECTED" FOR EBV-PLASMA ON (B)(6) 2025 AS WELL. THE PATIENT HAS A CHRONIC T-CELL EBV INFECTION AND HAS BEEN POSITIVE WITH COMPARABLE VALUES SINCE (B)(6) 2025 (CONFIRMED THROUGH REFERENCE LAB IN PARIS). THE CUSTOMER IS ALLEGING THAT ALL NOT DETECTED RESULTS FOR THAT PATIENT ARE QUESTIONED AS THE PATIENT HAS A KNOWN EBV INFECTION CONSTANTLY SHOWING SINCE (B)(6) 2025 (ALSO IN SEROLOGY). BASED ON THIS INFORMATION PROVIDED, THE CUSTOMER IS ALLEGING DISCREPANT FALSE NOT DETECTED RESULTS ON EBV-PLASMA (LIST NUMBER 09N43-91) FOR SID (B)(6) AND SID (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174860 ALINITY M EBV AMP KIT NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF EPSTEIN-BARR VIRUS (EBV) QLX ABBOTT MOLECULAR, INC. N/A 00884999049505

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown