# FDA recall Z-1438-2020

> **Polymer Technology Systems, Inc.** · Class II · device recall initiated 2020-01-21.

## 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.

## Distribution

Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.

## Key facts

- **Recall number:** Z-1438-2020
- **Recalling firm:** Polymer Technology Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-21
- **Report date:** 2020-03-11
- **Termination date:** 2020-12-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indianapolis, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1438-2020

## Citation

> AI Analytics. FDA recall Z-1438-2020. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1438-2020. Source: US FDA. Licensed CC0.

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