FDA Device recall Z-2024-2023
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
- FDA Device
- Class II
- ongoing
- Published 2023-07-05
On 2023-07-05 the FDA classified a Class II recall of VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 by Luminex, citing 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) c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2024-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-05 |
| Published | 2023-07-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Luminex |
| Distribution | US |
Product
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
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.
Identifiers
| code_info | UDI/DI , Lot Numbers: 071222022D, 100622022D |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2024-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.