BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I CMV IGG REAGENT KIT

    MDR report key: 24616196 · Received March 17, 2026

    Report

    Report Number
    3008344661-2026-00058
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    November 25, 2025
    Report Date
    May 13, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LFZ
    UDI-DI
    00380740129798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 7P42 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P42-24/-33, AND 510K/PMA/BLA OF K220949. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE POSITIVE ALINITY I CMV IGG RESULTS COMPARED TO ROCHE TECHNIQUE. SID (B)(6), (FEMALE) ON (B)(6) 2025, GENERATED ALINITY I CMV IGG REACTIVE OF 21.7 AU/ML. ADDITIONAL TESTING OF ALINITY I CMV IGM OF 1.25 INDEX, LOW POSITIVE. NO AVIDITY TESTING WAS PERFORMED. THE PATIENT WAS NOT PREGNANT ON THIS DATE. THE SAME PATIENT, USING ID (B)(6), ON (B)(6) 2026, GENERATED ALINITY I CMV IGG REACTIVE OF 24.1 AU/ML. ADDITIONAL TESTING OF ALINITY I CMV IGM OF 1.27 INDEX, LOW POSITIVE. THE SAMPLE WAS SENT TO ANOTHER LAB FOR AVIDITY TESTING, BECAUSE PATIENT WAS PREGNANT. ROCHE RESULT OF NO CMV IGG, SO AVIDITY COULD NOT BE RUN. THE CUSTOMER RETRIEVED THE SERUM SAMPLE FROM (B)(6) 2025 AND SENT TO ANOTHER LAB FOR AVIDITY TESTING. THE RESULT WAS NO CMV IGG. THE PATIENT IS KNOWN TO HAVE WEAKLY POSITIVE ANTI-CARDIOLIPIN IGM. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143851 ALINITY I CMV IGG REAGENT KIT ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS LFZ ABBOTT IRELAND DIAGNOSTICS DIVISION 80086FZ00 00380740129798

    Patients

    Seq Age Sex Outcome Treatment
    1