FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2641-2010
- Recalling firm
- Polymer Technology Systems, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2010-07-06
- Posted
- 2010-09-30
- Terminated
- 2011-05-11
- 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.
- Lot, serial or model codes
- Lot number I904
- 510(k) numbers
- ["K071507"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 3015525148
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28