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U.S. Department of Health and Human Services

Class 3 Device Recall Diagnostic Hybrids Inc.

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  Class 3 Device Recall Diagnostic Hybrids Inc. see related information
Date Initiated by Firm December 31, 2012
Date Posting Updated February 07, 2013
Recall Status1 Terminated 3 on December 05, 2013
Recall Number Z-0792-2013
Recall Event ID 64115
Product Classification Culture media, antimicrobial susceptibility test - Product Code LKA
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/
Diagnostic Hybrids Inc
1055 E State St
Suite 100
Athens OH 45701-7911
For Additional Information Contact Karl E. Luke, PhD
Manufacturer Reason
for Recall
RhMK product fungal contamination.
FDA Determined
Cause 2
Process control
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.