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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 3 Recall
Diagnostic Hybrids Inc.		see related information
Date Posted February 07, 2013
Recall Number Z-0792-2013
Product 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.
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.
Recalling Firm/
Manufacturer		 Diagnostic Hybrids Inc
1055 E State St
Suite 100
Athens, Ohio 45701-7911
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Karl E. Luke, PhD
740-589-3300
Reason for
Recall		 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 technicalsupport@quidel.com or by calling 800.874.1517, Monday through Friday, 8:00 a.m. to 5:00 p.m. EST.
Quantity in Commerce 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.
 
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