BEUDAMED
    FDA Enforcement Class II 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 · Reported April 10, 2013

    Enforcement

    Recall Number
    Z-1060-2013
    Event ID
    64537
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Polymedco, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 10, 2013
    Initiation Date
    February 12, 2013
    Classification Date
    April 4, 2013
    Termination Date
    February 10, 2016
    Address
    510 Furnace Dock Rd, N/A, Cortlandt Manor, NY, 10567-6220, United States

    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.

    Code Info

    Kit Lot # P207830 - Kit Expiration Date 2/28/2013 - Test Strip Lot # 18005M; Kit Lot # P210191 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M Kit Lot # P210192 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X010M; Kit Lot # P217033 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y011M; Kit Lot # P217034 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y012M; Kit Lot # P217035 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M; Kit Lot # P222808 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M.

    Distribution

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

    Quantity

    229,600 test strips