FDA Device recall Z-1438-2020
PTS Detect Cotinine, Ref
- FDA Device
- Class II
- terminated
- Published 2020-03-11
On 2020-03-11 the FDA classified a Class II recall of PTS Detect Cotinine, Ref by Polymer Technology Systems, citing the firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1438-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-21 |
| Published | 2020-03-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Polymer Technology Systems |
| Distribution | US |
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
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
Identifiers
| upc | 381933061017 |
|---|---|
| code_info | 1811715 1831313 1831324 1831325 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1438-2020%22
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