Recall Z-0078-2007 ยท GMZ Antigens, All Types, Escherichia Coli
Hardy Media Inc Dba Hardy Diag
HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy Diagnostics, Santa Maria, CA 93455
| Date | Oct 27, 2006 (initiated Aug 21, 2006) |
| Status | Terminated |
| Reason | Performance failure; the product is failing to show pigment development for E. coli 0157. |
| Root cause | Other |
| Action | Customers were first notified by phone on 8/21/06. Then all customers are faxed and mailed a signed recall letter via first class mail. All customers will be contacted, calling every few days until all have responded and all product reconciliation is made. A second recall notice was mailed 09/25/06 to include the original lot (#06192) plus an additional lot (#06235). Customers will be instructed to dispose of all remaining inventory. Hardy Diagnostics will credit or replace their purchase. |
| Quantity | 850 plates |
| Distribution | Nationwide Distribution, including the states of CA, IL, ME, NV, OK, TX, UT, WA & WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.