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U.S. Department of Health and Human Services

Class 3 Device Recall PTS Panels LDL Cholesterol test strips

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  Class 3 Device Recall PTS Panels LDL Cholesterol test strips see related information
Date Initiated by Firm May 29, 2008
Date Posted March 15, 2010
Recall Status1 Terminated 3 on October 20, 2010
Recall Number Z-1132-2010
Recall Event ID 53759
510(K)Number K040693  
Product Classification system, test, low density, lipoprotein - Product Code MRR
Product PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN; Catalog No. 1753.

For the quantitative measurement of LDL cholesterol in whole blood.
Code Information Lots L771, exp. 12/04/08 and L781, exp. 12/17/2008.
Recalling Firm/
Manufacturer		 Polymer Technology Systems, Inc.
7736 Zionsville Rd
Indianapolis IN 46268-2175
For Additional Information Contact
877-870-5610
Manufacturer Reason
for Recall		 The expiration date was extended by 20 weeks without justification.
FDA Determined
Cause 2		 Process change control
Action An "URGENT-FIELD CORRECTION" letter dated May 29, 2008, was sent to customers. The letter described the product, problem and action to be taken by the customers. The customers are to please immediately identify the number of remaining LDL kits they currently have remaining in inventory of the specified lots and indicate the amount on the included Customer Acknowledgement and Confirmation letter and return via fax to 217-870-5608. The firm will ship a new lot of the LDL Cholesterol strips with new expiration dates to the customers. The customers are to please save the updated information and make the appropriate changes to their records. If you have any questions, please contact Customer Service at 317-870-5610 or toll-free at 877-870-5610.
Quantity in Commerce not available.
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 = MRR and Original Applicant = POLYMER TECHNOLOGY SYSTEMS, INC.
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