Lipid Panel test strips — Class II medical device recall Z-1372-2019
Terminated recall by Polymer Technology Systems, Inc., reported 2019-05-29, distributed nationwide. Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which co
| Recall number | Z-1372-2019 |
|---|---|
| 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 | 2019-01-16 |
| Classified | 2019-05-23 |
| Reported by FDA | 2019-05-29 |
| Terminated | 2020-06-24 |
| Distributed | Nationwide (US) |
| Quantity | 67,643 total |
| Reason classes | labeling |
| Model numbers | 2729, 570-0412 |
Product
Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
Reason for recall
Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
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-1372-2019. 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.