BEUDAMED
    FDA Recall Open, Classified

    ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

    Recall: Z-1950-2019 · Initiated August 8, 2018

    Recall

    Recall Number
    Z-1950-2019
    Event Number
    83088
    Firm
    Helena Laboratories, Corp.
    FEI Number
    1618982
    Product Code
    KHE
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 8, 2018
    Address
    1530 Lindbergh Dr, Beaumont, TX, 77707-4131

    Description

    ColoCARE, Cat. No. 5651, packaged 50 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.

    Action

    The recalling firm made notifications beginning 8/8/2018 via phone and letter delivered via email. Customers were to dispose of the product.

    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

    328/50-pouch kits