BEUDAMED
    FDA Recall Terminated

    epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.

    Recall: Z-1971-2013 · Initiated March 13, 2013

    Recall

    Recall Number
    Z-1971-2013
    Event Number
    65126
    Firm
    Epocal
    FEI Number
    3004959793
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 13, 2013
    Posted
    August 14, 2013
    Terminated
    August 31, 2016
    Address
    2935 Conroy Rd, Ottawa Canada Ontario

    Description

    epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.

    Reason

    This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end of the Glucose test sensor (>400 mg/dl). Specifically, after a period of storage of three (3) to four (4) months, the Glucose sensor may report low results at the high end of the measurement range.

    Action

    On March 13th 2013, Epocal placed all CT-1004-00-00 test card on shipment hold. Affected product in Epocal control has been segregated and quarantined. Beginning on March 26 2013, Epocal Inc. plans to begin distribution of the Recall Notification Letter to the 4 direct consignees (customers/distributors) via certified mail. Included with the Recall Notification Letter is a faxback verification form. Notification will include all distribution channels to the end-user level. Direct consignees are instructed to discontinue use and discard all stock on hand, complete the provided faxback verification form to document disposal and contact their consignees to advise them of the notification and disposal of affected product.

    Distribution

    Worldwide Distribution-USA (nationwide) including the District of Columbia, US Virgin Islands and Puerto Rico, and the states of CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MS, NC, ND, NE, NH, NJ, NM, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, VE, WA, WI, and WV and the coutries of India, Argentina, Australia, Azerbaijan, Belarus, Canada, China, Colombia, Egypt, Germany, Guatemala, Israel, Japan, Malaysia, Mexico, Nepal, Netherlands, Peru, Philippines, Russia Fed., Singapore, South Africa, South korea, Thailand, and Vietnam.

    Quantity

    828,750 Test Card