Z-0078-2007

HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy...

Name: Z-0078-2007 HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy...
Creator: Hardy Media Inc Dba Hardy Diag
Published: 2006-08-21
License: https://open.fda.gov/license/

Hardy Diagnostics / initiated 2006-08-21 / Terminated

FDA source

Hardy Media Inc Dba Hardy Diag began a recall of HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy Diagnostics, Santa Maria, CA 93455 on 2006-08-21. The reason FDA records is "Performance failure; the product is failing to show pigment development for E. coli 0157". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0078-2007
Status: Terminated
Initiated: 2006-08-21
Posted: 2006-10-27
Terminated: 2011-06-14
Recalling firm: Hardy Diagnostics
Product: HardyCHROM 0157, Catalogue Number: G305, Lot Numbers: 06192 & 06235, Packaged: 10 plates per sleeve, Hardy Diagnostics, Santa Maria, CA 93455
Product code: GMZ Antigens, All Types, Escherichia Coli
Reason for recall: Performance failure; the product is failing to show pigment development for E. coli 0157.
FDA 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 in commerce: 850 plates
Distribution: Nationwide Distribution, including the states of CA, IL, ME, NV, OK, TX, UT, WA & WY
Product codes and lots: Lot numbers: 06192 (exp: 10/09/2006) and 06235 (exp:10/22/2006)

Product code GMZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)