Z-0239-04

DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET

Name: Z-0239-04 DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET
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 DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET on 2003-03-20. The reason FDA records is "Lacks professional use labeling and firm name and address". 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-0239-04
Status: Terminated
Initiated: 2003-03-20
Posted: 2003-12-18
Terminated: 2003-12-17
Recalling firm: Drug Free Enterprises
Product: DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET.
Product code: DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Reason for recall: Lacks professional use labeling and firm name and address.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Firm sent letters and stickers to customers in April 2003 asking them to overlabel existing stocks and to tell the firm how many were overlabeled. Recall is complete.
Quantity in commerce: 2800 units
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)