BEUDAMED
    FDA Enforcement Class II Terminated

    BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies

    Recall: Z-1867-2012 · Reported July 4, 2012

    Enforcement

    Recall Number
    Z-1867-2012
    Event ID
    61768
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 4, 2012
    Initiation Date
    December 1, 2010
    Classification Date
    June 25, 2012
    Termination Date
    March 5, 2014
    Address
    500 GBC Drive, Mailstop 514, PO BOX 6101, Newark, DE, 19714-6101, United States

    Description

    BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies

    Reason

    Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithrombin assay using the INNOVANCE(R) Antithrombin kit, and the test immediately following is an APTT based clotting assay several results may be shortened.

    Code Info

    Device catalog No. OVIO03 (not lot specific)

    Distribution

    Worldwide Distribution - US (nationwide) including the states of: AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IO, KS, KY, LA, MD, MA, MI, MS, MN, MT, NE, NH, NJ, NY, NC, ND, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV, and WI and the countries of: Australia, France, Canary Islands, Spain, Belgium, Germany, Switzerland, Netherlands, Italy, Guadeloupe, Ceuta, Austria, Slovenia, Croatia, Saudi Arabia, Turkey, Greece, and San Marino.

    Quantity

    186