Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay
FDA device recall Z-2039-2012 · posted 2012-07-19 · Terminated
Recall details
- Recalling firm
- Alere San Diego, Inc.
- Reason for recall
- A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may have significantly decreased precision and accuracy than claimed. An increased frequency of false positive and/or false negative results has been observed for Triage TOX Drug Screen.
- Action taken
- Alere sent an Urgent Medical Device Recall letter dated June 11, 2012 to all affected customers. The letter informed the customers of the affected product, problem identified and actions to be taken. Customers were instructed to discontinue all use of the recalled lots, immediately inform clinicians of this recall at the testing site(s) and complete and fax the enclosed customer verification form and list of affected lots within 10 days to confirm receipt of the letter. Customers with questions about the information contained in the recall letter, can contact Alere San Diego at 9975 Summers Ridge Road, San Diego, CA 92121 or call (877) 308-8287.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DJR
- Quantity affected
- 9,997 kits
- Distribution
- US Nationwide Distribution
- Date initiated
- 2012-05-14
- Date posted
- 2012-07-19
- Date terminated
- 2012-12-04
- 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 |