BEUDAMED
    FDA Recall Open, Classified

    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543

    Recall: Z-0180-2022 · Initiated September 20, 2021

    Recall

    Recall Number
    Z-0180-2022
    Event Number
    88784
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    CEK
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    September 20, 2021
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543

    Reason

    The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c results may affect consideration of intervention.

    Action

    On September 20, 2021, the firm distributed Urgent Medical Device Correction letters to impacted customers. Atellica customers were informed that the resolution of the issue will be implemented in SW v1.25.1. ADVIA customers were informed that the resolution of the issue will be implemented in AP Tool v1.11 and TDef v.1.07. These updates will be available soon. In the interim, customers were provided additional instructions to work around the issue until the update is available. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.

    Distribution

    Worldwide distribution - US Nationwide distribution.

    Quantity

    1402 (US); 2941 (OUS)