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Polymer Technology Systems, Inc. recalls PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system
Recalled March 11, 2020 · FDA recall Z-1438-2020 · Polymer Technology Systems
Hazard
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance. · FDA Class II
Units
6790
Sold at
Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.
Description
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
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.
Manufacturer(s)
Polymer Technology Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →