BEUDAMED
    FDA Enforcement Class III Completed

    PTS Panels CHOL+GLU Test Strips (REF 1765)

    Recall: Z-1741-2022 · Reported September 21, 2022

    Enforcement

    Recall Number
    Z-1741-2022
    Event ID
    90791
    Classification
    Class III
    Status
    Completed
    Product Type
    Devices
    Firm
    Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2022
    Initiation Date
    August 16, 2022
    Classification Date
    September 14, 2022
    Address
    4600 Anson Blvd, Whitestown, IN, 46075-4489, United States

    Description

    PTS Panels CHOL+GLU Test Strips (REF 1765)

    Reason

    Incorrect instructions for use were packaged into the final product.

    Code Info

    Complete UDI: (01)00381931765016(17)230627(10)A202 UPC Code: 381931765016 lot A202

    Distribution

    Worldwide distribution - US Nationwide distribution in the state of Virginia and the countries of Japan and Russia.