Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually pouched devices in a labeled kit b
FDA device recall Z-1446-2012 · posted 2012-04-20 · Terminated
Recall details
- Recalling firm
- Alere San Diego dba Biosite Innovacon Hemosense Inc
- Reason for recall
- The recall was initiated because Biosite Inc. received an increase in customer calls regarding unexpected positive THC results when using the Triage TOX Drug Screen.
- Action taken
- Biosite sent a "PRODUCT ADVISORY NOTICE" letter dated March 12, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter states that customers may continue to use the product. Customers were instructed to complete and fax an enclosed verification form to Technical Services at 1-858-695-7100. Customers with any questions about the information contained in the notification were instructed to contact Biosite Inc. at (888) 246-7483.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DJR
- Quantity affected
- 1,258,002 kits
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada and European Union.
- Date initiated
- 2010-03-12
- Date posted
- 2012-04-20
- Date terminated
- 2012-04-23
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIAGE TOX DRUG SCREEN, MODEL 94400 (K060791) | Biosite Incorporated | 2006-06-22 |