Official recall record
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-06-05
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Luminex Corporation
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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