BEUDAMED
    FDA Recall Open, Classified

    Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038

    Recall: Z-0193-2022 · Initiated October 6, 2021

    Recall

    Recall Number
    Z-0193-2022
    Event Number
    88865
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    CDT
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    October 6, 2021
    Address
    500 Gbc Dr, Newark, DE, 19702-2466

    Description

    Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower. SMN 10703038

    Reason

    The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical interpretations and clinical decisions.

    Action

    On October 6, 2021, the firm notified affected customers via an "Urgent Medical Device Correction" letter. Customers were informed of the product issue and provided instructions on actions to be taken by laboratories, which prevent the issue from happening. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. A new version of the Firmware for the Aptio Automation Interface Module to the ADVIA Centaur XP/XPT will correct the issue. Your service provider will contact you to schedule the firmware upgrade.

    Distribution

    Worldwide distribution.

    Quantity

    1142