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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 Recall
CardioChek PTS Panels CHOLHDLGLU
see related information
Date Posted September 30, 2010
Recall Status1 Terminated on May 11, 2011
Recall Number Z-2641-2010
Recall Event ID 56188
Premarket Notification
510(K) Number
K071507 
Product Classification System, Test, Blood Glucose, Over The Counter - 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, Indiana 46268-2175
Manufacturer Reason
for Recall
The test strips appear to under-recover Cholesterol, HDL and glucose.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NBW and Original Applicant = POLYMER TECHNOLOGY SYSTEMS, INC.
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