BEUDAMED
    FDA Recall Terminated

    Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens.

    Recall: Z-0792-2013 · Initiated December 31, 2012

    Recall

    Recall Number
    Z-0792-2013
    Event Number
    64115
    Firm
    Diagnostic Hybrids Inc
    FEI Number
    1000122536
    Product Code
    LKA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 31, 2012
    Posted
    February 7, 2013
    Terminated
    December 5, 2013
    Address
    1055 E State St, Suite 100, Athens, OH, 45701-7911

    Description

    Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens.

    Reason

    RhMK product fungal contamination.

    Action

    Diagnostic Hybrids sent a Urgent: Medical Device Recall letter dated December 31, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to immediately review your inventory and determine if you have any of the affected product. If so, please remove it from inventory. Complete the enclosed Product Recall Fax-Back form. Upon receipt of Fax-Back form, Diagnostic Hybrids will send you replacement product or issue credit. Representatives are available to assist you in this process and answer any questions you may have about this recall, and how to obtain replacement product. Please contact Technical Support at [email protected] or by calling 800.874.1517, Monday through Friday, 8:00 a.m. to 5:00 p.m. EST.

    Distribution

    Nationwide Distribution including the states of AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA & WI.

    Quantity

    13,005 units