BEUDAMED
    FDA Recall Terminated

    PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1795. The product is used to measure total cholesterol, and HDL cholesterol, in whole blood.

    Recall: Z-0975-2010 · Initiated February 20, 2009

    Recall

    Recall Number
    Z-0975-2010
    Event Number
    53761
    Firm
    Polymer Technology Systems, Inc.
    FEI Number
    3015525148
    Product Code
    CHH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 20, 2009
    Posted
    April 2, 2010
    Terminated
    October 20, 2010
    Address
    7736 Zionsville Rd, Indianapolis, IN, 46268-2175

    Description

    PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1795. The product is used to measure total cholesterol, and HDL cholesterol, in whole blood.

    Reason

    Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009 expiration date.

    Action

    Consignees were notified by letter dated Febuary 20, 2009, advised of the problem, and that the firm would replace product not consumed by the true expiration date. Direct questions to Polymer Technology Systems, Inc.

    Distribution

    Worldwide Distribution.

    Quantity

    3,748 vials