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Class 2 Device Recall CardioChek PTS panels |
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Date Initiated by Firm |
August 04, 2009 |
Date Posted |
March 05, 2010 |
Recall Status1 |
Terminated 3 on October 20, 2010 |
Recall Number |
Z-1012-2010 |
Recall Event ID |
53246 |
510(K)Number |
K071507
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Product Classification |
Glucose oxidase, glucose - Product Code CGA
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Product |
PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN. |
Code Information |
Lot I891. |
Recalling Firm/ Manufacturer |
Polymer Technology Systems, Inc. 7736 Zionsville Rd Indianapolis IN 46268-2175
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For Additional Information Contact |
317-870-5610
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Manufacturer Reason for Recall |
Possible under recovery of cholesterol, HDL and glucose. A loss of recoverable cholesterol and HDL cholesterol is a manageable to moderate health risk. The clinical applications analysis shows that lot 1891 shows such a loss of activity. A loss of recoverable Glucose measurement is a moderate to high risk, based upon the degree of under-recovery, and the frequency of occurrence.
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by letter dated 7/28/09 to discontinue use of, and to destroy, the reagent and to contact the firm for replacement product. For questions, please contact the company Customer Service toll-free at 877-870-5610 or + 1-317-870-5610 (outside the US). |
Quantity in Commerce |
962 |
Distribution |
Nationwide. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = CGA and Original Applicant = POLYMER TECHNOLOGY SYSTEMS, INC.
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