FDA Medical Device Recalls (openFDA)
Abbott Health Products, Inc.: TDx/TDxFLx Opiates Reagent, Product list number: 9673-60
- Recall number
- Z-1229-04
- Recalling firm
- Abbott Health Products, Inc.
- Product
- TDx/TDxFLx Opiates Reagent, Product list number: 9673-60
- Status
- Terminated
- Initiated
- 2004-05-28
- Posted
- 2004-07-28
- Terminated
- 2004-09-10
- Reason
- Abbott Diagnostics Division has found that the oxymorphone cross-reactivity information in the 'Specific Performance Characteristics' section of the TDx/TDxFLx Opiates Reagent package insert (commodity number 32-2087/R5) does not match the current product performance.
- Root cause
- Other
- Action
- A Device Correction Letter dated 5/28/04 was mailed to all customers. The letter explained the reason for the recall and provided specific instructions.
- Quantity
- 941 kits
- Distribution
- Distribution was to hospitals/laboratories
- Lot, serial or model codes
- Lot/Unit numbers Exp. date 10750Q100 9/22/04 09650Q100 9/15/04
- 510(k) numbers
- ["K874485"]
- PMA numbers
- not on file
- Product code
- DJG
- 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