PTS Panels¿ CHOL+GLU Test Strips — Class II medical device recall Z-1543-2018
Terminated recall by Polymer Technology Systems, Inc., reported 2018-05-09, distributed in FL, IL, KY, MN, NY, OH, PR, TN…. Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (Au
| Recall number | Z-1543-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Polymer Technology Systems, Inc., Indianapolis, IN, United States |
| Recall initiated | 2018-03-14 |
| Classified | 2018-04-28 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2018-09-13 |
| Distributed | FL, IL, KY, MN, NY, OH, PR, TN, VA, WA |
| Countries outside the US | AU, BE, BR, GB, HK, RU, SE |
| UPC / GTIN / UDI-DI | 00381931765016 |
| Lot numbers | A705 |
| Model numbers | 1765 |
Product
PTS Panels¿ CHOL+GLU Test Strips (REF 1765)
Reason for recall
Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)
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-1543-2018. 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.