Recall Z-2641-2010 ยท NBW System, Test, Blood Glucose, Over The Counter
Polymer Technology Systems, Inc.
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.
| Date | Sep 30, 2010 (initiated Jul 6, 2010) |
| Status | Terminated |
| Reason | The test strips appear to under-recover Cholesterol, HDL and glucose. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071507 | PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS Polymer Technology Systems, Inc., Sep 10, 2007 |