FDA Medical Device Recalls (openFDA)
Luminex Corporation: VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
- Recall number
- Z-2024-2023
- Recalling firm
- Luminex Corporation
- Product
- VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
- Status
- Open, Classified
- Initiated
- 2023-06-05
- Posted
- 2023-06-28
- Terminated
- not on file
- Reason
- It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.
- Root cause
- Other
- Action
- Luminex issued an Urgent Field Safety Notice - Medical Device Recall notice on 06/05/2023 by email. The notice explained the problem with the stool prep kit, the risk, and requested isolation/quarantine, cease of use, and disposal of the affected products.
- Quantity
- 114 units
- Distribution
- Worldwide and US Nationwide Distribution
- Lot, serial or model codes
- UDI/DI , Lot Numbers: 071222022D, 100622022D
- 510(k) numbers
- K123197
- PMA numbers
- not on file
- Product code
- OZN
- Firm FEI
- 3006028115
- Firm city
- Northbrook
- Firm state
- IL
- Firm country
- not on file
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