VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
- Company
- Luminex Corporation
- Recall Initiated
- June 5, 2023
- Posted
- June 28, 2023
- Recall Number
- Z-2024-2023
- Quantity
- 114 units
- Firm Location
- Northbrook, IL
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
Lot / Code Info
UDI/DI , Lot Numbers: 071222022D, 100622022D
Root Cause
Other
Action Taken
Luminex issued an Urgent Field Safety Notice - Medical Device Recall notice on 06/05/2023 by email. The notice explained the problem with the stool prep kit, the risk, and requested isolation/quarantine, cease of use, and disposal of the affected products.
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