BEUDAMED
    FDA Enforcement Class II Terminated

    HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.

    Recall: Z-2192-2015 · Reported July 29, 2015

    Enforcement

    Recall Number
    Z-2192-2015
    Event ID
    71577
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hardy Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 29, 2015
    Initiation Date
    June 24, 2015
    Classification Date
    July 22, 2015
    Termination Date
    August 28, 2015
    Address
    1430 W Mccoy Ln, N/A, Santa Maria, CA, 93455-1005, United States

    Description

    HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.

    Reason

    Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.

    Code Info

    Cat No.: G333 Lot No.: H15055

    Distribution

    Distributed to one U.S. customer in SC.

    Quantity

    1,500