Class 2 Device Recall PTS Panels Lipids Panel test strips

• Date Initiated by Firm: June 05, 2009
• Date Posted: March 15, 2010
• Recall Status: Terminated on October 20, 2010
• Recall Number: Z-1136-2010
• Recall Event ID: 53773
• 510(K)Number: K022898 K023558
• Product Classification: in vitro diagnostic - Product Code CHH
• Product: 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.
• Code Information: Lot P814; exp. 9/2/09.
• 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: Exhibits under-recovery of all analytes.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Consignees were notified by letter dated 6/5/09, advised of the problem, and that the firm would replace product.
• Quantity in Commerce: Not available.
• Distribution: Nationwide and international.
• 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