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U.S. Department of Health and Human Services

Class 2 Device Recall PTS Panels Lipids Panel test strips

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  Class 2 Device Recall PTS Panels Lipids Panel test strips see related information
Date Initiated by Firm June 05, 2009
Date Posted March 15, 2010
Recall Status1 Terminated 3 on October 20, 2010
Recall Number Z-1136-2010
Recall Event ID 53773
510(K)Number K023558  K022898  
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 2		 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 and Original Applicant = POLYMER TECHNOLOGY SYSTEMS, INC.
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