Z-0792-2013 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 13, 2013
- Initiation Date
- December 31, 2012
- Termination Date
- December 5, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,005 units
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.
Distribution Pattern
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.