BEUDAMED
    FDA Enforcement Class II Ongoing

    ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

    Recall: Z-1949-2019 · Reported July 17, 2019

    Enforcement

    Recall Number
    Z-1949-2019
    Event ID
    83088
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Helena Laboratories, Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 17, 2019
    Initiation Date
    August 8, 2018
    Classification Date
    July 5, 2019
    Address
    1530 Lindbergh Dr, Beaumont, TX, 77707-4131, United States

    Description

    ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

    Reason

    The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.

    Code Info

    Kit lots 1-17-5650, exp. 8/31/2018, and 2-17-5650, exp. 9/30/2018. These kit lots contain ColoCARE pad lot numbers 1-17-551039, exp. 8/31/2018, and 2-17-551039, exp. 9/30/2018.

    Distribution

    Distribution was made to AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, ND, NE, NV, NY, OH, OK, PA, SD, TN, TX, VA, WA, and WY. There was no foreign/military/government distribution.

    Quantity

    27/250 pouch kits