FDA Medical Device Recalls (openFDA)
Polymer Technology Systems, Inc.: PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN; Catalog No. 1753. For the quantitative measurement of LDL cholesterol in whole blood.
- Recall number
- Z-1132-2010
- Recalling firm
- Polymer Technology Systems, Inc.
- Product
- PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN; Catalog No. 1753. For the quantitative measurement of LDL cholesterol in whole blood.
- Status
- Terminated
- Initiated
- 2008-05-29
- Posted
- 2010-03-15
- Terminated
- 2010-10-20
- Reason
- The expiration date was extended by 20 weeks without justification.
- Root cause
- Process change control
- Action
- An "URGENT-FIELD CORRECTION" letter dated May 29, 2008, was sent to customers. The letter described the product, problem and action to be taken by the customers. The customers are to please immediately identify the number of remaining LDL kits they currently have remaining in inventory of the specified lots and indicate the amount on the included Customer Acknowledgement and Confirmation letter and return via fax to 217-870-5608. The firm will ship a new lot of the LDL Cholesterol strips with new expiration dates to the customers. The customers are to please save the updated information and make the appropriate changes to their records. If you have any questions, please contact Customer Service at 317-870-5610 or toll-free at 877-870-5610.
- Quantity
- not available.
- Distribution
- Worldwide distribution
- Lot, serial or model codes
- Lots L771, exp. 12/04/08 and L781, exp. 12/17/2008.
- 510(k) numbers
- ["K040693"]
- PMA numbers
- not on file
- Product code
- MRR
- 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