AxSYM Tricyclic Antidepressants Reagent, Distributed under the following label: AxSYM Tricyclic Antidepressants Reagents
FDA device recall Z-0323-04 · posted 2004-01-10 · Terminated
Recall details
- Recalling firm
- Abbott Health Products, Inc.
- Reason for recall
- Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.
- Action taken
- The Important Information Letter dated 11/17/03 was mailed to all ADx, TDx/TDxFL and AxSYM TCA reagent customers. The letters were sent to customers by Federal express Priority mail. The letter recommended contacting all customers who have received the reagents within the last 15 months.
- Root cause
- Other
- Status
- Terminated
- Product code
- LDM
- Distribution
- Distribution was nationwide.
- Date initiated
- 2003-11-17
- Date posted
- 2004-01-10
- Date terminated
- 2004-11-02
- 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 |
|---|---|---|
| AXSYM TRICYCLIC ANTIDEPRESSANTS (K953761) | Abbott Laboratories | 1995-11-22 |