Product Brand Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476), Triage Drugs of Abuse Panel Plus TCA (K973784), &
FDA device recall Z-1130-2012 · posted 2012-03-01 · Terminated
Recall details
- Recalling firm
- Alere San Diego
- Reason for recall
- Alere San Diego received a rise in customer complaints regarding false positive Barbiturates (BAR) results on the Triage Drugs of Abuse Panel Plus TCA.
- Action taken
- Alere sent a "PRODUCT NOTIFICATION" letter dated January 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Verification Form was enclosed for customers to complete and return to the firm. Contact Technical Services at 1-877-308-8287.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DIS
- Quantity affected
- 693054 kits
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, EU, Guatemala, Japan, Lebanon, and Saudi Arabia.
- Date initiated
- 2012-01-04
- Date posted
- 2012-03-01
- Date terminated
- 2013-07-05
- 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 PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS (K973784) | Biosite Incorporated | 1997-12-03 |
| THE TRIAGE II (K924476) | Biosite Incorporated | 1993-01-22 |