Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intende
FDA device recall Z-2460-2012 · posted 2012-09-26 · Terminated
Recall details
- Recalling firm
- Alere San Diego, Inc.
- Reason for recall
- Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots: AMP, BAR, and PCP, the threshold ranges may not be consistently set correctly in all meters.
- Action taken
- Alere sent a 'NOTICE OF CORRECTION" letter dated July 12, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers with questions were instructed to contact Technical Services at (877) 308-8287. Customers were instructed to complete the Customer/Distributor Verification Form Notice of Correction even if they do not have any involved product and fax back to Technical Services at (858) 805-8457 or scan and email to responses.ts@alere.com.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LDP
- Quantity affected
- 591 kits
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-07-12
- Date posted
- 2012-09-26
- Date terminated
- 2013-02-01
- 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 |
| TRIAGE TOX DRUG SCREEN (K043242) | Biosite Incorporated | 2005-02-28 |