Class II — Medtox Diagnostics Inc
| Recalling firm | MEDTOX DIAGNOSTICS, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing. |
| Product | PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine, |
| Quantity | 221,625 |
| Distribution | Worldwide distribution: USA (nationwide) and in the country of: Canada. |
| Initiated | 2013-04-05 |
| Classified | 2013-05-16 |
| Terminated | 2013-09-12 |
| Recall number | Z-1329-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medtox Diagnostics Inc (Z-1329-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64800/
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