BEUDAMED
    FDA Recall Open, Classified

    ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)

    Recall: Z-2088-2025 · Initiated June 4, 2025

    Recall

    Recall Number
    Z-2088-2025
    Event Number
    97037
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    JCN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 4, 2025
    Posted
    July 3, 2025
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)

    Reason

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

    Action

    An Urgent Medical Device Correction notification dated 6/4/25 was mailed to consignees. This notification provides consignees with calibration instructions given the issue found in affected lots. Additionally, instructions are given on how to proceed with product depending on performance. Consignees are to discontinue use of and discard of the calibrator SETPOINT lots impacted by this recall. Consignee locations are to review the provided notification with their Medical Directors to determine the appropriate course of action. A copy of the recall notification should be retained in laboratory records and shared with users. Consignees are to complete and return the provided Effectiveness Check Form within 30 days of receipt of the recall notification. Consignees with any questions can contact their Siemens Customer Care Center or local Siemens Healthineers technical support representative.

    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

    3,435 units