[Recalled] PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine, — Review of validation information and customer complaints which indicated prelim… | FDA 2013-04-05
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine, |
|---|---|
| Brand / manufacturer | Medtox Diagnostics Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1329-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 05 April 2013 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.