Class 2 Device Recall PTS Detect Cotinine

• Date Initiated by Firm: January 21, 2020
• Date Posted: February 20, 2020
• Recall Status: Terminated on December 14, 2020
• Recall Number: Z-1438-2020
• Recall Event ID: 84840
• Product Classification: Test system, nicotine, cotinine, metabolites - Product Code MRS
• 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.
• Code Information: 1811715 1831313 1831324 1831325
• FEI Number: 3015525148
• Recalling Firm/ Manufacturer: Polymer Technology Systems, Inc.; 7736 Zionsville Rd; Indianapolis IN 46268-2175
• For Additional Information Contact: Theresa Florczak; 317-870-5610
• Manufacturer Reason for Recall: The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
• FDA Determined Cause: No Marketing Application
• Action: 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 response@ptsdiagnostics.com.
• Quantity in Commerce: 6790
• Distribution: Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.