Class III — Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
| Recalling firm | POLYMER TECHNOLOGY SYSTEMS, INC. |
|---|---|
| Registered facility | Polymer Technology Systems (the firm's only registered facility) |
| Classification | Class III |
| Status | Completed |
| Reason | Incorrect instructions for use were packaged into the final product. |
| Product | PTS Panels CHOL+GLU Test Strips (REF 1765) |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of Virginia and the countries of Japan and Russia. |
| Initiated | 2022-08-16 |
| Classified | 2022-09-14 |
| Recall number | Z-1741-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. (Z-1741-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90791/
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