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

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide and US Nationwide Distribution Quantity: 114 units Lot/code info: UDI/DI , Lot Numbers: 071222022D, 100622022D

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.