BEUDAMED
    FDA Recall Terminated

    PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN; Catalog No. 1753. For the quantitative measurement of LDL cholesterol in whole blood.

    Recall: Z-1132-2010 · Initiated May 29, 2008

    Recall

    Recall Number
    Z-1132-2010
    Event Number
    53759
    Firm
    Polymer Technology Systems, Inc.
    FEI Number
    3015525148
    Product Code
    MRR
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    May 29, 2008
    Posted
    March 15, 2010
    Terminated
    October 20, 2010
    Address
    7736 Zionsville Rd, Indianapolis, IN, 46268-2175

    Description

    PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN; Catalog No. 1753. For the quantitative measurement of LDL cholesterol in whole blood.

    Reason

    The expiration date was extended by 20 weeks without justification.

    Action

    An "URGENT-FIELD CORRECTION" letter dated May 29, 2008, was sent to customers. The letter described the product, problem and action to be taken by the customers. The customers are to please immediately identify the number of remaining LDL kits they currently have remaining in inventory of the specified lots and indicate the amount on the included Customer Acknowledgement and Confirmation letter and return via fax to 217-870-5608. The firm will ship a new lot of the LDL Cholesterol strips with new expiration dates to the customers. The customers are to please save the updated information and make the appropriate changes to their records. If you have any questions, please contact Customer Service at 317-870-5610 or toll-free at 877-870-5610.

    Distribution

    Worldwide distribution

    Quantity

    not available.