Z-2024-2023 Class II Ongoing
FDA device recall Z-2024-2023 was initiated by Luminex Corporation on June 5, 2023 and is designated Class II. 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-… The recall status is ongoing. Affected quantity: 114 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 5, 2023
- Initiation Date
- June 5, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 114 units
Product Description
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
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 Pattern
Worldwide and US Nationwide Distribution
Code Information
UDI/DI , Lot Numbers: 071222022D, 100622022D