Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media...
FDA Recall #Z-0792-2013 — Class III — December 31, 2012
Product 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 for Recall
RhMK product fungal contamination.
Recalling Firm
Diagnostic Hybrids Inc — Athens, OH
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
13,005 units
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.
Code Information
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated