BEUDAMED
    FDA Enforcement Class II Terminated

    ACL TOP CTS, automated coagulation laboratory instrument.

    Recall: Z-2062-2014 · Reported July 23, 2014

    Enforcement

    Recall Number
    Z-2062-2014
    Event ID
    68578
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instrumentation Laboratory Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 23, 2014
    Initiation Date
    June 3, 2014
    Classification Date
    July 16, 2014
    Termination Date
    September 21, 2017
    Address
    180 Hartwell Road, N/A, Bedford, MA, 01730-2443, United States

    Description

    ACL TOP CTS, automated coagulation laboratory instrument.

    Reason

    Potential for sample misidentification.

    Code Info

    Start SN and Date: 06020101 Feb 2006 End SN and Date 10080662 Aug 2010

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV, and the countries of Canada, Mexico, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Brunei, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Quatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Venezuela, Vietnam.

    Quantity

    572