Recall Z-1329-2013 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Medtox Diagnostics Inc
PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,
| Date | May 16, 2013 (initiated Apr 5, 2013) |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | MEDTOX issued "URGENT MEDICAL DEVICE RECALL" letters dated April 3, 2013 to consignees informing them of the recall. The letter requested that they examine their inventory and immediately discontinue all use and distribution of the affected lots. The letter also requested that they immediately inform clinicians of the recall at the testing sites that have utilized the recall product. The letter also included a Customer Verification Form which was to be returned. |
| Quantity | 221,625 |
| Distribution | Worldwide distribution: USA (nationwide) and in the country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080635 | MEDTOXSCAN Medtox Diagnostics, Inc., Feb 13, 2009 |