BEUDAMED
    FDA Recall Terminated

    Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use.

    Recall: Z-0463-2013 · Initiated October 24, 2012

    Recall

    Recall Number
    Z-0463-2013
    Event Number
    63615
    Firm
    Sekisui Diagnostics Llc
    FEI Number
    1220602
    Product Code
    GGP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 24, 2012
    Posted
    December 3, 2012
    Terminated
    January 8, 2013
    Address
    500 West Avenue, Stamford, CT, 06902

    Description

    Sekisui Diagnostics, Spectrolyse PAI-1 In-Vitro Diagnostic Use for the quantitative determination of Plasminogen Activator Inhibitor Type 1 in human plasma. Catalog # 101201. Spectrolyse PAI-1 is intended for the quantitative determination of Plasminogen Activator Inhibitor Type-1 (PAI-1) activity in human plasma. The test is for in vitro diagnostic use.

    Reason

    Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing the slope of the standard curve requiring more frequent sample dilutions.

    Action

    Sekisui Diagnostics issued an "URGENT PRODUCT RECALL NOTICE" dated October 24, 2012 to all consignees. The letter instructed consignees to immediately stop using the specified lot of product, discard any remaining inventory and return the enclosed response form. Contact the Customer Service Department at 800-637-3375, ext. 10, 12, or 31 for assistance with this recall.

    Distribution

    Nationwide Distribution-including the states of FL, IN, NC, OH, UT, and WA.

    Quantity

    63 kits