BEUDAMED
    FDA Enforcement Class II Terminated

    BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.

    Recall: Z-1435-2021 · Reported April 28, 2021

    Enforcement

    Recall Number
    Z-1435-2021
    Event ID
    87590
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 28, 2021
    Initiation Date
    March 2, 2021
    Classification Date
    April 19, 2021
    Termination Date
    June 10, 2022
    Address
    511 Benedict Ave, N/A, Tarrytown, NY, 10591-5005, United States

    Description

    BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma.

    Reason

    Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.

    Code Info

    (UDI) 00630414945514

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and the countries of Argentina, Austria, Belarus, Belgium, Bosnia Herzegovina, Brazil, Canada, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Lebanon, Macedonia, Mexico, Montenegro, Netherlands, P. R. China, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Uruguay.

    Quantity

    1547 assays