Polymer Technology Systems, Inc. recalls PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine syste…

Recall date

January 21, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1438-2020

FDA classification

Class II

Brand / firm

Polymer Technology Systems, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.