BEUDAMED
    FDA Enforcement Class II Terminated

    CHOL+HDL+GLU test strips, REF 2412

    Recall: Z-1373-2019 · Reported May 29, 2019

    Enforcement

    Recall Number
    Z-1373-2019
    Event ID
    82331
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Polymer Technology Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 29, 2019
    Initiation Date
    January 16, 2019
    Classification Date
    May 23, 2019
    Termination Date
    June 24, 2020
    Address
    7736 Zionsville Rd, N/A, Indianapolis, IN, 46268-2175, United States

    Description

    CHOL+HDL+GLU test strips, REF 2412

    Reason

    Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed

    Code Info

    I808 I809 I811 I812 I814

    Distribution

    Domestic distribution nationwide.

    Quantity

    67643 total