BEUDAMED
    FDA Recall Terminated

    PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc. Catalog # 1710.

    Recall: Z-1136-2010 · Initiated June 5, 2009

    Recall

    Recall Number
    Z-1136-2010
    Event Number
    53773
    Firm
    Polymer Technology Systems, Inc.
    FEI Number
    3015525148
    Product Code
    CHH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 5, 2009
    Posted
    March 15, 2010
    Terminated
    October 20, 2010
    Address
    7736 Zionsville Rd, Indianapolis, IN, 46268-2175

    Description

    PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc. Catalog # 1710.

    Reason

    Exhibits under-recovery of all analytes.

    Action

    Consignees were notified by letter dated 6/5/09, advised of the problem, and that the firm would replace product.

    Distribution

    Nationwide and international.

    Quantity

    Not available.