BEUDAMED
    FDA Recall Terminated

    PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.

    Recall: Z-1012-2010 · Initiated August 4, 2009

    Recall

    Recall Number
    Z-1012-2010
    Event Number
    53246
    Firm
    Polymer Technology Systems, Inc.
    FEI Number
    3015525148
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 4, 2009
    Posted
    March 5, 2010
    Terminated
    October 20, 2010
    Address
    7736 Zionsville Rd, Indianapolis, IN, 46268-2175

    Description

    PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.

    Reason

    Possible under recovery of cholesterol, HDL and glucose. A loss of recoverable cholesterol and HDL cholesterol is a manageable to moderate health risk. The clinical applications analysis shows that lot 1891 shows such a loss of activity. A loss of recoverable Glucose measurement is a moderate to high risk, based upon the degree of under-recovery, and the frequency of occurrence.

    Action

    Consignees were notified by letter dated 7/28/09 to discontinue use of, and to destroy, the reagent and to contact the firm for replacement product. For questions, please contact the company Customer Service toll-free at 877-870-5610 or + 1-317-870-5610 (outside the US).

    Distribution

    Nationwide.

    Quantity

    962