BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1438-2020 · Initiated January 21, 2020

    Recall

    Recall Number
    Z-1438-2020
    Event Number
    84840
    Firm
    Polymer Technology Systems, Inc.
    FEI Number
    3015525148
    Product Code
    MRS
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    January 21, 2020
    Posted
    February 20, 2020
    Terminated
    December 14, 2020
    Address
    7736 Zionsville Rd, Indianapolis, IN, 46268-2175

    Description

    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.

    Reason

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

    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 [email protected].

    Distribution

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

    Quantity

    6790