BEUDAMED
    FDA Enforcement Class III Terminated

    Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.

    Recall: Z-2200-2021 · Reported August 11, 2021

    Enforcement

    Recall Number
    Z-2200-2021
    Event ID
    88323
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stanbio Laboratory, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 11, 2021
    Initiation Date
    July 12, 2021
    Classification Date
    August 5, 2021
    Termination Date
    March 29, 2022
    Address
    1261 N Main St, Boerne, TX, 78006-3014, United States

    Description

    Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.

    Reason

    Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

    Code Info

    Catalog Number/Product Description: 2441-050U/¿-Hydroxybutyrate Reagent A - Enzyme (unlabeled) Lot Numbers: 158894;

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Chile, Federal Republic of Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Viet Nam.

    Quantity

    200 units