BEUDAMED
    FDA Enforcement Class III Terminated

    McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178¿TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178¿CK30

    Recall: Z-1080-2019 · Reported April 10, 2019

    Enforcement

    Recall Number
    Z-1080-2019
    Event ID
    82312
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cypress Medical Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2019
    Initiation Date
    February 27, 2019
    Classification Date
    March 30, 2019
    Termination Date
    May 21, 2021
    Address
    9954 Mayland Dr, N/A, Richmond, VA, 23233-1464, United States

    Description

    McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178¿TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178¿CK30

    Reason

    Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the packaging being too similar to domestically sourced products under the same branded label.

    Code Info

    All lots

    Distribution

    Shipped to distribution centers located in AL, AR, AZ, CA, CO, FL, GA, HI, IL, KY, LA, MA, MN, MO, MS, NH, NJ, NY, OH, PA, SC, TN, TX, UT, VA, WA, and WI.

    Quantity

    1165 cases