BEUDAMED
    FDA Enforcement Class II Ongoing

    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

    Recall: Z-2542-2025 · Reported September 17, 2025

    Enforcement

    Recall Number
    Z-2542-2025
    Event ID
    97398
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    September 17, 2025
    Initiation Date
    August 11, 2025
    Classification Date
    September 8, 2025
    Address
    511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States

    Description

    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

    Reason

    Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.

    Code Info

    Material Number: 11097543. Test Code: UCFP. UDI-DI: 00630414279206. All lot numbers.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Macedonia, Malaysia, Maldives, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, U.A.E., United¿Kingdom, Uruguay, Vatikancity, Vietnam, Zaire.

    Quantity

    11,811 units