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.
FDA Recall Z-0792-2013 · Posted 2013-02-07
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Recalling FirmDiagnostic Hybrids Inc
Recall StatusTerminated
Product CodeLKA
Date Initiated2012-12-31
Date Terminated2013-12-05
Product Quantity13,005 units
Reason for Recall
RhMK product fungal contamination.
Firm 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 [email protected] or by calling 800.874.1517, Monday through Friday, 8:00 a.m. to 5:00 p.m. EST.
Root Cause
Process control
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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