BEUDAMED
    FDA Recall Terminated

    ACL TOP (Base), automated coagulation laboratory instrument.

    Recall: Z-2060-2014 · Initiated June 3, 2014

    Recall

    Recall Number
    Z-2060-2014
    Event Number
    68578
    Firm
    Instrumentation Laboratory Co.
    FEI Number
    1217183
    Product Code
    GKP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 3, 2014
    Posted
    July 16, 2014
    Terminated
    September 21, 2017
    Address
    180 Hartwell Road, Bedford, MA, 01730-2443

    Description

    ACL TOP (Base), automated coagulation laboratory instrument.

    Reason

    Potential for sample misidentification.

    Action

    Consignees were notified via phone starting on June 3, 2014. On June 4, a USPS mailing was sent to all US/Canadian customers. On June 4, 2014, email notifications were sent to the IL Affiliates and International Distributors/Dealers (through the International Group) requesting them to translate the Field Safety Notice and provide notification to their customer base and secondary distributors. The Urgent Product Correction letter informs consignees of the issue and provides workaround instructions. Consignees are asked to complete a Mandatory Response Tracking Record and return it via Fax (781)861-4207 or email: [email protected]. For technical questions, consignees should contact the IL Technical Support Center at 1-800-678-0710.

    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

    1074