FDA Medical Device Recalls (openFDA)
Abbott Health Products, Inc.: TDx/TDxFLx TDx/TDxFLX Tricyclic Antidepressant Reagent Distributed under the following label: TDx/TDxFLX, Abbott Laboratories USA, North Chicago, IL 60064
- Recall number
- Z-0691-03
- Recalling firm
- Abbott Health Products, Inc.
- Product
- TDx/TDxFLx TDx/TDxFLX Tricyclic Antidepressant Reagent Distributed under the following label: TDx/TDxFLX, Abbott Laboratories USA, North Chicago, IL 60064
- Status
- Terminated
- Initiated
- 2002-12-11
- Posted
- 2003-03-29
- Terminated
- 2004-06-02
- Reason
- Unexpected false positive TCA results
- Root cause
- Other
- Action
- 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.
- Quantity
- not on file
- 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, Taiwan, Thailand, Costa Rica, New Zealand and Panama
- Lot, serial or model codes
- List no. 9681-60
- 510(k) numbers
- ["K853113"]
- PMA numbers
- not on file
- Product code
- 91
- 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