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Luminex Corporation recalls Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
Recalled July 5, 2023 · FDA recall Z-2023-2023 · Luminex
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. · FDA Class II
Units
3987 units
Sold at
Worldwide and US Nationwide Distribution
Description
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.
Product
Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
Manufacturer(s)
Luminex Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →