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Terminated

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

FDA Recall Z-0078-2007 · Posted 2006-10-27

Recalling FirmHardy Media Inc Dba Hardy Diag
Recall StatusTerminated
Product CodeGMZ
Date Initiated2006-08-21
Date Terminated2011-06-14
Product Quantity850 plates

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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