Polymer Technology Systems, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1438-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 21, 2020

Date Posted: March 11, 2020

Recall Number: Z-1438-2020

Event ID: 84840

Reason for Recall:

The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.

Status: Terminated

Product Quantity: 6790

Code Information:

1811715 1831313 1831324 1831325

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated