FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0078-2007
- Recalling firm
- Hardy Media Inc Dba Hardy Diag
- Product
- HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy Diagnostics, Santa Maria, CA 93455
- Status
- Terminated
- Initiated
- 2006-08-21
- Posted
- 2006-10-27
- Terminated
- 2011-06-14
- 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
- Lot, serial or model codes
- Lot numbers: 06192 (exp: 10/09/2006) and 06235 (exp:10/22/2006)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GMZ
- Firm FEI
- 2022807
- Firm city
- Santa Maria
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28