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U.S. Department of Health and Human Services

Class 2 Device Recall CardioChek PTS Panels CHOLHDLGLU

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  Class 2 Device Recall CardioChek PTS Panels CHOLHDLGLU see related information
Date Initiated by Firm July 06, 2010
Date Posted September 30, 2010
Recall Status1 Terminated 3 on May 11, 2011
Recall Number Z-2641-2010
Recall Event ID 56188
510(K)Number K071507  
Product Classification blood glucose test system - Product Code NBW
Product PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polymer Technology Systems, Inc., 7736 Zionsville Rd., Indianapolis, IN 46268.
Code Information Lot number I904
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		 The test strips appear to under-recover Cholesterol, HDL and glucose.
FDA Determined
Cause 2		 Other
Action Distributors and direct customers were notified by letter on July 2, 2010. They were told to discontinue use and dispose of the affected lot of test strips. The firm also asked customers to complete an acknowledgement and confirmation document .
Quantity in Commerce 5805
Distribution US accounts in: CA, MA, FL, NY, KY, VA, UT, MN, OH, and MD. Direct foreign accounts in: Belgium, England, Sweden, and Italy.
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 = NBW and Original Applicant = POLYMER TECHNOLOGY SYSTEMS, INC.
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