BEUDAMED
    FDA Enforcement Class II 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 · Reported March 11, 2020

    Enforcement

    Recall Number
    Z-1438-2020
    Event ID
    84840
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Polymer Technology Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2020
    Initiation Date
    January 21, 2020
    Classification Date
    March 4, 2020
    Termination Date
    December 14, 2020
    Address
    7736 Zionsville Rd, N/A, Indianapolis, IN, 46268-2175, United States

    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.

    Code Info

    1811715 1831313 1831324 1831325

    Distribution

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

    Quantity

    6790