Z-1202-03

On-Site Alcohol IVD A single use enzymatic assay for qualitative detection of alcohol in urine or saliva...

Name: Z-1202-03 On-Site Alcohol IVD A single use enzymatic assay for qualitative detection of alcohol in urine or saliva...
Creator: Varian, Inc.
Published: 2003-07-18
License: https://open.fda.gov/license/

Varian, Inc. / initiated 2003-07-18 / Terminated

FDA source

Varian, Inc. began a recall of On-Site Alcohol IVD A single use enzymatic assay for qualitative detection of alcohol in urine or saliva. Catalog numbers: 47464 Roche Diagnostics Label... on 2003-07-18. The reason FDA records is "Stability in question". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1202-03
Status: Terminated
Initiated: 2003-07-18
Posted: 2003-09-12
Terminated: 2004-05-17
Recalling firm: Varian, Inc.
Product: On-Site Alcohol IVD A single use enzymatic assay for qualitative detection of alcohol in urine or saliva. Catalog numbers: 47464 Roche Diagnostics Label A305-02 Varian, Inc. label
Product code: DML Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
Reason for recall: Stability in question.
FDA root cause: Other
Action: Recall letter was sent on July 18, 2003 which instructs to stop using affected product and return it for free replacement.
Quantity in commerce: 11847 kits (50 units/kit)
Distribution: Nationwide
Product codes and lots: None given.

Product code DML

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)