VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Reported: July 5, 2023 Initiated: June 5, 2023 #Z-2024-2023
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.
Details
- Recalling Firm
- Luminex Corporation
- Units Affected
- 114 units
- Distribution
- Worldwide and US Nationwide Distribution
- Location
- Northbrook, IL
Frequently Asked Questions
What product was recalled? ▼
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022. Recalled by Luminex Corporation. Units affected: 114 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 5, 2023. Severity: Moderate. Recall number: Z-2024-2023.
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