Z-1246-03

Drug Check 4 Test Cup AMP/COC/OPI/THC Product Code 60400, and 60410

Name: Z-1246-03 Drug Check 4 Test Cup AMP/COC/OPI/THC Product Code 60400, and 60410
Creator: Drug Free Enterprises Inc
Published: 2003-03-20
License: https://open.fda.gov/license/

Drug Free Enterprises / initiated 2003-03-20 / Terminated / root cause: labeling and UDI

FDA source

Drug Free Enterprises Inc began a recall of Drug Check 4 Test Cup AMP/COC/OPI/THC Product Code 60400, and 60410 on 2003-03-20. The reason FDA records is "Label lacks professional use legend and name and address of the manufacturer". 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-1246-03
Status: Terminated
Initiated: 2003-03-20
Posted: 2003-09-23
Terminated: 2003-09-22
Recalling firm: Drug Free Enterprises
Product: Drug Check 4 Test Cup AMP/COC/OPI/THC Product Code 60400, and 60410
Product code: DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Reason for recall: Label lacks professional use legend and name and address of the manufacturer.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm sent a letter to customers requesting that they overlabel their stock on 3/20/2003. This recall is complete.
Quantity in commerce: Undetermined.
Distribution: Nationwide
Product codes and lots: All codes

Product code DIO

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)