VERIGENE Clostridium difficile Nucleic Acid Test — Class II medical device recall Z-2024-2023
Ongoing recall by Luminex Corporation, reported 2023-07-05, distributed nationwide. It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VER
| Recall number | Z-2024-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Northbrook, IL, United States |
| Recall initiated | 2023-06-05 |
| Classified | 2023-06-28 |
| Reported by FDA | 2023-07-05 |
| Distributed | Nationwide (US) |
| Quantity | 114 units |
| Reason classes | microbial contamination |
| Lot numbers | 071222022D, 100622022D |
| Model numbers | 30-002-022 |
Product
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2024-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.