| Class 2 Device Recall CardioChek PTS Panels CHOLHDLGLU | |
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
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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
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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 |
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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 = NBW
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