Z-0542-04

Nitrate Reagent A, Cat No. Z71, Lot 3338 Nitrate Reagent B, Cat No. A72, Lot 3338

Name: Z-0542-04 Nitrate Reagent A, Cat No. Z71, Lot 3338 Nitrate Reagent B, Cat No. A72, Lot 3338
Creator: Hardy Media Inc Dba Hardy Diag
Published: 2003-12-31
License: https://open.fda.gov/license/

Hardy Diagnostics / initiated 2003-12-31 / Terminated / root cause: labeling and UDI

FDA source

Hardy Media Inc Dba Hardy Diag began a recall of Nitrate Reagent A, Cat No. Z71, Lot 3338 Nitrate Reagent B, Cat No. A72, Lot 3338 on 2003-12-31. The reason FDA records is "Mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0542-04
Status: Terminated
Initiated: 2003-12-31
Posted: 2004-02-24
Terminated: 2004-05-17
Recalling firm: Hardy Diagnostics
Product: Nitrate Reagent A, Cat No. Z71, Lot 3338 Nitrate Reagent B, Cat No. A72, Lot 3338
Product code: JTO Discs, Strips And Reagents, Microorganism Differentiation
Reason for recall: Mislabeled.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Customers were first notified by telephone on 12/31/2003. Then customers are mailed a sigh\ned recall letter via first class mail. All customers will be contacted by telephone to reconcile returns.
Quantity in commerce: 39 bottles of Z71 and 6 bottles of Z72
Distribution: TX, CA, ID, Puerto Rico, KS, WY,
Product codes and lots: Lot 3338.

Product code JTO

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)