Recall Z-1451-06 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Hardy Media Inc Dba Hardy Diag
BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Lot# 06136
| Date | Aug 29, 2006 (initiated Jun 27, 2006) |
| Status | Terminated |
| Reason | This recall is being conducted due to the performance failure nearing the end of the product shelf life. |
| Root cause | Other |
| Action | Customers were first notified by phone on 6/28/06, then all customers were faxed and mailed a signed recall letter via first class mail. |
| Quantity | 860 plates |
| Distribution | Nationwide in AZ, CA, IA, ID, MI, MT, NC, & WY. Plus: Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964560 | BHI W/VANCOMYCIN AGAR Hardy Diagnostics, Jan 15, 1997 |