medical Class II Updated 2023-07-05

Luminex Corporation recalls VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI/DI , Lot Numbers: 071222022D, 100622022D
View official government recall

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