TDx/TDxFLx TDx/TDxFLX Tricyclic Antidepressant Reagent Distributed under the following label: TDx/TDxFLX, Abbott Laborat
FDA device recall Z-0691-03 · posted 2003-03-29 · Terminated
Recall details
- Recalling firm
- Abbott Health Products, Inc.
- Reason for recall
- Unexpected false positive TCA results
- Action taken
- A Device Correction letter was mail to all customers on 12 /11/02. The letter explained the reason for the recall and provided specific instructions.
- Root cause
- Other
- Status
- Terminated
- Product code
- 91
- Distribution
- Distribution was nationwide, VA/DOD accounts. The foreign distribution was as follows: Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Canada, England, Japan, Singapore, Hong Kong, Tai
- Date initiated
- 2002-12-11
- Date posted
- 2003-03-29
- Date terminated
- 2004-06-02
- Location
- Barceloneta, PR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TD TRICYCLIC ANTIDEPRESSANTS (K853113) | Abbott Laboratories | 1985-08-12 |