PROFILE-V MEDTOXScan Drugs of Abuse Test System — Class II medical device recall Z-1329-2013
Terminated recall by Medtox Diagnostics Inc, reported 2013-05-22, distributed nationwide. Review of validation information and customer complaints which indicated preliminary screen positive results f
| Recall number | Z-1329-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtox Diagnostics Inc, Burlington, NC, United States |
| Recall initiated | 2013-04-05 |
| Classified | 2013-05-16 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2013-09-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 221,625 |
| Lot numbers | 6041, 6051, 6061, 6071, 6081, 6091, 6321, 6331, 6341, 6351, 6361, 6371, 6551, 6552, 6561, 6562, 6563, 6564, 6571, 6581, 6582, 6583, 6584, 6591, 6592, 6593, 6601, 6602, 6603, 6611, 6612, 6621, 6622, 6623, 6631, 6632, 6641, 6651, 6652, 6661 and 36 more |
| Model numbers | 604018, 604019, 604020, 604022, 604026, 604028 |
Product
PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,
Reason for recall
Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1329-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.