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Recall Observatory FDA recall evidence

Device product

VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022

Z-2024-2023

June 05, 2023

Class II

Product summary

Firm
Luminex Corporation
Event
Event 92451
Status
Ongoing
Classification
Class II
Quantity
114 units
Official record key
device-enforcement:Z-2024-2023

Official wording

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.

Code information: UDI/DI , Lot Numbers: 071222022D, 100622022D

Distribution pattern: Worldwide and US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.