RecallDepth

HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy Diagnostics, Santa Maria, CA 93455

Company
Hardy Media Inc Dba Hardy Diag
Recall Initiated
August 21, 2006
Posted
October 27, 2006
Terminated
June 14, 2011
Recall Number
Z-0078-2007
Quantity
850 plates
Firm Location
Santa Maria, CA

Reason for Recall

Performance failure; the product is failing to show pigment development for E. coli 0157.

Distribution

Nationwide Distribution, including the states of CA, IL, ME, NV, OK, TX, UT, WA & WY

Lot / Code Info

Lot numbers: 06192 (exp: 10/09/2006) and 06235 (exp:10/22/2006)

Root Cause

Other

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.

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