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U.S. Department of Health and Human Services

Class 2 Device Recall CardioChek PTS panels

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 Class 2 Device Recall CardioChek PTS panelssee related information
Date Initiated by FirmAugust 04, 2009
Date PostedMarch 05, 2010
Recall Status1 Terminated 3 on October 20, 2010
Recall NumberZ-1012-2010
Recall Event ID 53246
510(K)NumberK071507 
Product Classification Glucose oxidase, glucose - Product Code CGA
ProductPTS 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
For Additional Information Contact
317-870-5610
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.
FDA Determined
Cause 2		Other
ActionConsignees 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 Commerce962
DistributionNationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CGA
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