BEUDAMED
    FDA Enforcement Class II Terminated

    Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.

    Recall: Z-1571-2016 · Reported May 4, 2016

    Enforcement

    Recall Number
    Z-1571-2016
    Event ID
    73688
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hardy Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    May 4, 2016
    Initiation Date
    March 21, 2016
    Classification Date
    April 26, 2016
    Termination Date
    October 25, 2016
    Address
    1430 W McCoy Ln, N/A, Santa Maria, CA, 93455-1005, United States

    Description

    Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.

    Reason

    Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GBS) with the target QC organism, Streptococcus agalactiae (ATCC 13813) due to product deterioration.

    Code Info

    Lot H16054 and H15056.

    Distribution

    U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.

    Quantity

    3,530 (353 pk/10)