PTS Panels CHOL+GLU Test Strips — Class III medical device recall Z-1741-2022
Completed recall by Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc., reported 2022-09-21, distributed nationwide. Incorrect instructions for use were packaged into the final product.
| Recall number | Z-1741-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc., Whitestown, IN, United States |
| Recall initiated | 2022-08-16 |
| Classified | 2022-09-14 |
| Reported by FDA | 2022-09-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP, RU |
| UPC / GTIN / UDI-DI | 00381931765016 |
| Lot numbers | A202 |
| Model numbers | 1765 |
Product
PTS Panels CHOL+GLU Test Strips (REF 1765)
Reason for recall
Incorrect instructions for use were packaged into the final product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1741-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.