PTS Panels CHOL+HDL+GLU Test Strips — Class II medical device recall Z-0741-2020
Terminated recall by Polymer Technology Systems, Inc., reported 2020-01-01, distributed in CA, CT, FL, IN, MA, MD, MI, MN…. This lot of test strips is showing an under-recovery when tested against a reference method.
| Recall number | Z-0741-2020 |
|---|---|
| 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 | 2016-03-15 |
| Classified | 2019-12-26 |
| Reported by FDA | 2020-01-01 |
| Terminated | 2020-06-05 |
| Distributed | CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, WI |
| Countries outside the US | AU, BE, GB, ID, IT, PL, VN, ZA |
| Quantity | 6,467 |
| UPC / GTIN / UDI-DI | 00381932412018 |
| Lot numbers | I502 |
Product
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Reason for recall
This lot of test strips is showing an under-recovery when tested against a reference method.
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-0741-2020. 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.