BEUDAMED
    FDA Enforcement Class III Ongoing

    OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)

    Recall: Z-0538-2026 · Reported November 26, 2025

    Enforcement

    Recall Number
    Z-0538-2026
    Event ID
    97860
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 26, 2025
    Initiation Date
    October 6, 2025
    Classification Date
    November 17, 2025
    Address
    510 Furnace Dock Rd, Cortlandt Manor, NY, 10567-6220, United States

    Description

    OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test)

    Reason

    A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be 2027-01-17.

    Code Info

    UDI: 00855574005520, Catalog Number(s): OCQN Lot Number(s): Lot 250805

    Distribution

    USA: AK AL,AR,AZ, CA,CO,CT,DC,DE,FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, ,WI, WV, WY, Canada: AB, ON

    Quantity

    403 units