BEUDAMED
    FDA Enforcement Class II Terminated

    HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com

    Recall: Z-2463-2015 · Reported September 2, 2015

    Enforcement

    Recall Number
    Z-2463-2015
    Event ID
    71804
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hardy Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 2, 2015
    Initiation Date
    July 9, 2015
    Classification Date
    August 26, 2015
    Termination Date
    November 10, 2015
    Address
    1430 W Mccoy Ln, N/A, Santa Maria, CA, 93455-1005, United States

    Description

    HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com

    Reason

    Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot.

    Code Info

    Cat no. G307 Lot no. H15155

    Distribution

    Distributed in the states of VA, PA, NY, NJ, IL, OH, and MD.

    Quantity

    2,820 (282 pk/10)