Recall Z-0792-2013 ยท LKA Culture Media, Antimicrobial Susceptibility Test
Diagnostic Hybrids Inc
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.
| Date | Feb 7, 2013 (initiated Dec 31, 2012) |
| Status | Terminated |
| Reason | RhMK product fungal contamination. |
| Root cause | 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 ans |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.