BEUDAMED
    FDA Enforcement Class III Terminated

    Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499

    Recall: Z-0441-2021 · Reported November 18, 2020

    Enforcement

    Recall Number
    Z-0441-2021
    Event ID
    86586
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hardy Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 18, 2020
    Initiation Date
    October 6, 2020
    Classification Date
    November 9, 2020
    Termination Date
    May 28, 2021
    Address
    1430 W McCoy Ln, Santa Maria, CA, 93455-1005, United States

    Description

    Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499

    Reason

    Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10

    Code Info

    Lot # 465086

    Distribution

    US: VA, AR, WI, ID, NY, AL, CA, MT, TX, MN, NH, WA, NC, NY, AZ, AK, MO, FL, MI, WY, ID, CO, AL, MT, WY, Puerto Rico, and Guam

    Quantity

    8,620 units