BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Lot# 06136
FDA device recall Z-1451-06 · posted 2006-08-29 · Terminated
Recall details
- Recalling firm
- Hardy Media Inc Dba Hardy Diag
- Reason for recall
- This recall is being conducted due to the performance failure nearing the end of the product shelf life.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JSO
- Quantity affected
- 860 plates
- Distribution
- Nationwide in AZ, CA, IA, ID, MI, MT, NC, & WY. Plus: Puerto Rico
- Date initiated
- 2006-06-27
- Date posted
- 2006-08-29
- Date terminated
- 2011-06-14
- Location
- Santa Maria, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BHI W/VANCOMYCIN AGAR (K964560) | Hardy Diagnostics | 1997-01-15 |