Class 3 Device Recall PTS Panels CHOLHDL Panel test strips

• Date Initiated by Firm: February 20, 2009
• Date Posted: April 02, 2010
• Recall Status: Terminated on October 20, 2010
• Recall Number: Z-0975-2010
• Recall Event ID: 53761
• 510(K)Number: K071593
• Product Classification: Enzymatic esterase--oxidase, cholesterol - Product Code CHH
• Product: 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.
• Code Information: Lot G751.
• FEI Number: 3015525148
• Recalling Firm/ Manufacturer: Polymer Technology Systems, Inc.; 7736 Zionsville Rd; Indianapolis IN 46268-2175
• For Additional Information Contact: 317-870-5610
• Manufacturer Reason for Recall: Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009 expiration date.
• FDA Determined Cause: Process control
• 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.
• Quantity in Commerce: 3,748 vials
• Distribution: Worldwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CHH