BEUDAMED
    FDA Enforcement Class II Ongoing

    ADVIA¿ 120/2120/2120i SETpoint Calibrator

    Recall: Z-2086-2025 · Reported July 9, 2025

    Enforcement

    Recall Number
    Z-2086-2025
    Event ID
    97037
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2025
    Initiation Date
    June 4, 2025
    Classification Date
    July 3, 2025
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005, United States

    Description

    ADVIA¿ 120/2120/2120i SETpoint Calibrator

    Reason

    Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

    Code Info

    Siemens Material Number 10312285; UDI: 00630414224343, 00630414224343; Lot No. SP251033, SP251043.

    Distribution

    Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA, CL, CN, CO, CR, HK, ID, IN, JP, KR, MX, MY, PE, PY, SA, SG, TH, TW, UY, VN, & ZA.

    Quantity

    2,020 units