BEUDAMED
    FDA Recall 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 · Initiated June 24, 2015

    Recall

    Recall Number
    Z-2192-2015
    Event Number
    71577
    Firm
    Hardy Diagnostics
    FEI Number
    2022807
    Product Code
    JSO
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    June 24, 2015
    Posted
    July 22, 2015
    Terminated
    August 28, 2015
    Address
    1430 W Mccoy Ln, Santa Maria, CA, 93455-1005

    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.

    Action

    The firm initially called customers to inform them of the recall. The firm's phone script stated that they were discontinuing the product and as part of the process were recalling anything that still might be within expiration date. The phone script stated that the firm was going to be sending something in writing. On 06/24/15 the firm sent out a notification letters to customers to inform them that they were discontinuing the product, and were requested anything remaining within expiration to be discarded. The firm requests that customers complete, sign, and fax back the enclosed form stating their compliance with the above action. For any questions the firm states to contact Technical Services Department at 800-266-222, option 2 or via email at [email protected].

    Distribution

    Distributed to one U.S. customer in SC.

    Quantity

    1,500