BEUDAMED
    FDA Enforcement Class III 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 · Reported February 13, 2013

    Enforcement

    Recall Number
    Z-0792-2013
    Event ID
    64115
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diagnostic Hybrids Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 13, 2013
    Initiation Date
    December 31, 2012
    Classification Date
    February 7, 2013
    Termination Date
    December 5, 2013
    Address
    1055 E State St, Suite 100, Athens, OH, 45701-7911, United States

    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.

    Code Info

    Model #:49-0600, Lot#, 491206T, 491216; Model #: 49-0600A, Lot#, -A-491206T, -A-491216, -A-491216B; Model #: 49-0102A, Lot#, -A-491206T, -A-491216 and Model #: 49-T075A, Lot#, -A-491206T, -A-491216.

    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