BEUDAMED
    FDA Enforcement Class II Terminated

    PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers

    Recall: Z-0741-2020 · Reported January 1, 2020

    Enforcement

    Recall Number
    Z-0741-2020
    Event ID
    84264
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Polymer Technology Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2020
    Initiation Date
    March 15, 2016
    Classification Date
    December 26, 2019
    Termination Date
    June 5, 2020
    Address
    7736 Zionsville Rd, Indianapolis, IN, 46268-2175, United States

    Description

    PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers

    Reason

    This lot of test strips is showing an under-recovery when tested against a reference method.

    Code Info

    Lot Number I502, UDI 00381932412018

    Distribution

    The products were distributed to the following US states: CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, and WI. The products were distributed to the following foreign countries: Australia, Belgium, Indonesia, Italy, Poland, South Africa, UK, and Vietnam.

    Quantity

    6467