Z-0792-2013 Class III Terminated
FDA device recall Z-0792-2013 was initiated by Diagnostic Hybrids Inc on December 31, 2012 and is designated Class III. Reason for recall: RhMK product fungal contamination. The recall status is terminated (terminated December 5, 2013). Affected quantity: 13,005 units.
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.