Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PTS Detect Cotinine Recalled by Polymer Technology Systems, Inc. Due to The firm is removing the product from the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Polymer Technology Systems, Inc. directly.
Affected Products
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.
Quantity: 6790
Why Was This Recalled?
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Polymer Technology Systems, Inc.
Polymer Technology Systems, Inc. has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report