FDA Medical Device Recalls (openFDA)
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.: PTS Panels CHOL+GLU Test Strips (REF 1765)
- Recall number
- Z-1741-2022
- Recalling firm
- Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
- Product
- PTS Panels CHOL+GLU Test Strips (REF 1765)
- Status
- Completed
- Initiated
- 2022-08-16
- Posted
- not on file
- Terminated
- not on file
- Reason
- Incorrect instructions for use were packaged into the final product.
- Root cause
- Labeling Change Control
- Action
- PTS Diagnostics notified customers on August 16, 2022, through an Urgent Medical Device Recall letter. Customers were instructed to return product for replacement. Distributors were asked to forward the notice to all customers/users who may have received the product. If you have any questions, please contact PTS Diagnostics' Customer Service directly, Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time at +1 317-870-5610 or 877-570-8610 (U.S. toll-free).
- Quantity
- not on file
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Virginia and the countries of Japan and Russia.
- Lot, serial or model codes
- Complete UDI: (01)00381931765016(17)230627(10)A202 UPC Code: 381931765016 lot A202
- 510(k) numbers
- ["K162282"]
- PMA numbers
- not on file
- Product code
- CGA
- Firm FEI
- 3002698769
- Firm city
- Whitestown
- 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