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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy Diagnostics, Santa Maria, CA 93455
Brand
Hardy Media Inc Dba Hardy Diag
Lot Codes / Batch Numbers
Lot numbers: 06192 (exp: 10/09/2006) and 06235 (exp:10/22/2006)
Products Sold
Lot numbers: 06192 (exp: 10/09/2006) and 06235 (exp:10/22/2006)
Hardy Media Inc Dba Hardy Diag is recalling HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, due to Performance failure; the product is failing to show pigment development for E. coli 0157.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Performance failure; the product is failing to show pigment development for E. coli 0157.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026