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U.S. Department of Health and Human Services

Class 3 Device Recall PTS Panels CHOLHDL Panel test strips

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  Class 3 Device Recall PTS Panels CHOLHDL Panel test strips see related information
Date Initiated by Firm February 20, 2009
Date Posted April 02, 2010
Recall Status1 Terminated 3 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.
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 2		 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 and Original Applicant = POLYMER TECHNOLOGY SYSTEMS, INC.
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