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.

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

The firm notified affected customers on January 21, 2020, via Urgent Medical Device Recall letter. The letter informed customers that the product had not received the necessary 510(k) clearance. Customers were asked to immediately segregate impacted product and hold for return to PTS Diagnostics. Distributors were asked to forward the notice and response form to all customers/users who may have received the product. All customers were asked to complete and return the attached acknowledgement form, even if they do not have affected product on hand. The firm's Customer Service team will contact customers upon receipt of the response form to arrange for return of the materials. If you have any questions regarding this recall, please contact the firm's Customer Service directly, Monday through Friday, 8AM-5PM EST, at +1 317-870-5610 or 877-870-5610 (toll-free), or via email at [email protected].