Class 2 Device Recall PTS Panels Cholesterol test strips

• Date Initiated by Firm: April 02, 2009
• Date Posted: March 01, 2010
• Recall Status: Terminated on October 20, 2010
• Recall Number: Z-0871-2010
• Recall Event ID: 53768
• 510(K)Number: K981493 K990688
• Product Classification: Enzymatic esterase--oxidase, cholesterol - Product Code CHH
• Product: PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1711. Intended to provide a quantitative measurement of total cholesterol in whole blood.
• Code Information: Lot Number: C908.
• 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: The memory chip was coded with incorrect product information.
• FDA Determined Cause: Process control
• Action: Polymer Technology Systems, Inc. issued an "Urgent - Field Correction" letter dated April 2, 2009. Consignees were advised of the problem and asked to identify how many kits were in inventory so that the firm could replace product. For further information, contact Polymer Technology Systems, Inc. Customer Service at 1-877-870-5610.
• Quantity in Commerce: 486 vials
• Distribution: Nationwide 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