PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine,
FDA device recall Z-1329-2013 · posted 2013-05-16 · Terminated
Recall details
- Recalling firm
- Medtox Diagnostics Inc
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DIO
- Quantity affected
- 221,625
- Distribution
- Worldwide distribution: USA (nationwide) and in the country of: Canada.
- Date initiated
- 2013-04-05
- Date posted
- 2013-05-16
- Date terminated
- 2013-09-12
- Location
- Burlington, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTOXSCAN (K080635) | Medtox Diagnostics, Inc. | 2009-02-13 |