FDA Medical Device Recalls (openFDA)
Polymer Technology Systems, Inc.: PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.
- Recall number
- Z-1012-2010
- Recalling firm
- Polymer Technology Systems, Inc.
- Product
- PTS Panels CHOL+HDL+GLU Panel test strips for professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.
- Status
- Terminated
- Initiated
- 2009-08-04
- Posted
- 2010-03-05
- Terminated
- 2010-10-20
- Reason
- Possible under recovery of cholesterol, HDL and glucose. A loss of recoverable cholesterol and HDL cholesterol is a manageable to moderate health risk. The clinical applications analysis shows that lot 1891 shows such a loss of activity. A loss of recoverable Glucose measurement is a moderate to high risk, based upon the degree of under-recovery, and the frequency of occurrence.
- Root cause
- Other
- Action
- Consignees were notified by letter dated 7/28/09 to discontinue use of, and to destroy, the reagent and to contact the firm for replacement product. For questions, please contact the company Customer Service toll-free at 877-870-5610 or + 1-317-870-5610 (outside the US).
- Quantity
- 962
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot I891.
- 510(k) numbers
- ["K071507"]
- PMA numbers
- not on file
- Product code
- CGA
- 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