Luminex Corporation VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Brand
Luminex Corporation
Lot Codes / Batch Numbers
UDI/DI, Lot Numbers: 071222022D, 100622022D
Products Sold
UDI/DI , Lot Numbers: 071222022D, 100622022D
Luminex Corporation is recalling VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 due to 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 Tes. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026