HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy Diagnostics,
FDA device recall Z-0078-2007 · posted 2006-10-27 · Terminated
Recall details
- Recalling firm
- Hardy Media Inc Dba Hardy Diag
- Reason for recall
- Performance failure; the product is failing to show pigment development for E. coli 0157.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GMZ
- Quantity affected
- 850 plates
- Distribution
- Nationwide Distribution, including the states of CA, IL, ME, NV, OK, TX, UT, WA & WY
- Date initiated
- 2006-08-21
- Date posted
- 2006-10-27
- Date terminated
- 2011-06-14
- Location
- Santa Maria, CA
Monitor recalls programmatically
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