BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported November 10, 2021

    Enforcement

    Recall Number
    Z-0193-2022
    Event ID
    88865
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 10, 2021
    Initiation Date
    October 6, 2021
    Classification Date
    November 2, 2021
    Address
    500 Gbc Dr, N/A, Newark, DE, 19702-2466, United States

    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.

    Code Info

    UDI 00630414596754

    Distribution

    Worldwide distribution.

    Quantity

    1142