BEUDAMED
    FDA Recall Terminated

    Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.

    Recall: Z-1060-2013 · Initiated February 12, 2013

    Recall

    Recall Number
    Z-1060-2013
    Event Number
    64537
    Firm
    Polymedco, Inc
    FEI Number
    1000119795
    Product Code
    KHE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 12, 2013
    Posted
    April 4, 2013
    Terminated
    February 10, 2016
    Address
    510 Furnace Dock Rd, Cortlandt Manor, NY, 10567-6220

    Description

    Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.

    Reason

    The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots.

    Action

    Polymedco initiated phone calls to clients on 2/12/13. When the contact was made with the client, an URGENT DEVICE RECALL letter and Fax Form were sent by e-mail/fax. Mass mailing of the URGENT DEVICE RECALL letter dated February 12, 2013 and Fax Form was done by First Class USPS on 2/14/13-2/18/13. The recall affects the test strips only. For questions, please contact Polymedco Technical Support at 1-800-431-2123 ext 285.

    Distribution

    Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.

    Quantity

    229,600 test strips