PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polyme
FDA device recall Z-2641-2010 · posted 2010-09-30 · Terminated
Recall details
- Recalling firm
- Polymer Technology Systems, Inc.
- Reason for recall
- The test strips appear to under-recover Cholesterol, HDL and glucose.
- Action taken
- 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 .
- Root cause
- Other
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 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.
- Date initiated
- 2010-07-06
- Date posted
- 2010-09-30
- Date terminated
- 2011-05-11
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS (K071507) | Polymer Technology Systems, Inc. | 2007-09-10 |