FDA Medical Device Recalls (openFDA)
Polymer Technology Systems, Inc.: PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1795. The product is used to measure total cholesterol, and HDL cholesterol, in whole blood.
- Recall number
- Z-0975-2010
- Recalling firm
- Polymer Technology Systems, Inc.
- Product
- PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1795. The product is used to measure total cholesterol, and HDL cholesterol, in whole blood.
- Status
- Terminated
- Initiated
- 2009-02-20
- Posted
- 2010-04-02
- Terminated
- 2010-10-20
- Reason
- Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009 expiration date.
- Root cause
- Process control
- Action
- Consignees were notified by letter dated Febuary 20, 2009, advised of the problem, and that the firm would replace product not consumed by the true expiration date. Direct questions to Polymer Technology Systems, Inc.
- Quantity
- 3,748 vials
- Distribution
- Worldwide Distribution.
- Lot, serial or model codes
- Lot G751.
- 510(k) numbers
- ["K071593"]
- PMA numbers
- not on file
- Product code
- CHH
- 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