FDA-Device2023-07-05Class II
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Luminex Corporation
Hazard
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.
Sold states
Worldwide and US Nationwide Distribution
Affected count
114 units
Manufactured in
4088 Commercial Ave, N/A, Northbrook, IL, United States
Products
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2024-2023Don't want to check this manually?
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