FDA Medical Device Recalls (openFDA)
Polymer Technology Systems, Inc.: PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc. Catalog # 1710.
- Recall number
- Z-1136-2010
- Recalling firm
- Polymer Technology Systems, Inc.
- Product
- PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc. Catalog # 1710.
- Status
- Terminated
- Initiated
- 2009-06-05
- Posted
- 2010-03-15
- Terminated
- 2010-10-20
- Reason
- Exhibits under-recovery of all analytes.
- Root cause
- Nonconforming Material/Component
- Action
- Consignees were notified by letter dated 6/5/09, advised of the problem, and that the firm would replace product.
- Quantity
- Not available.
- Distribution
- Nationwide and international.
- Lot, serial or model codes
- Lot P814; exp. 9/2/09.
- 510(k) numbers
- ["K022898","K023558"]
- 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