FDA Medical Device Recalls (openFDA)
Abbott Health Products, Inc.: TDx/TDxFLx Tricyclic Antidepressants Reagent. Distributed under the following label: TDx/TDxFLx Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064.
- Recall number
- Z-0325-04
- Recalling firm
- Abbott Health Products, Inc.
- Product
- TDx/TDxFLx Tricyclic Antidepressants Reagent. Distributed under the following label: TDx/TDxFLx Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064.
- Status
- Terminated
- Initiated
- 2003-11-17
- Posted
- 2004-01-10
- Terminated
- 2004-11-02
- Reason
- Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.
- Root cause
- Other
- Action
- 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.
- Quantity
- not on file
- Distribution
- Distribution was nationwide.
- Lot, serial or model codes
- Product List number: 9681-60
- 510(k) numbers
- ["K853113"]
- PMA numbers
- not on file
- Product code
- LFG
- Firm FEI
- 2623532
- Firm city
- Barceloneta
- Firm state
- not on file
- Firm country
- PR
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28