PTS Detect Cotinine — Class II medical device recall Z-1438-2020
Terminated recall by Polymer Technology Systems, Inc., reported 2020-03-11, distributed nationwide. The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearanc
| Recall number | Z-1438-2020 |
|---|---|
| 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 | 2020-01-21 |
| Classified | 2020-03-04 |
| Reported by FDA | 2020-03-11 |
| Terminated | 2020-12-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, KR, PL, ZA |
| Quantity | 6,790 |
| UPC / GTIN / UDI-DI | 00381933061017 |
| Model numbers | 3061 |
Product
PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.
Reason for recall
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
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-1438-2020. 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.