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U.S. Department of Health and Human Services

Class 2 Device Recall Luminex Verigene

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  Class 2 Device Recall Luminex Verigene see related information
Date Initiated by Firm June 05, 2023
Date Posted June 28, 2023
Recall Status1 Open3, Classified
Recall Number Z-2024-2023
Recall Event ID 92451
510(K)Number K123197  
Product Classification C. Difficile toxin gene amplification assay - Product Code OZN
Product VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Code Information UDI/DI , Lot Numbers: 071222022D, 100622022D
Recalling Firm/
Manufacturer		 Luminex Corporation
4088 Commercial Ave
Northbrook IL 60062-1829
For Additional Information Contact
847-400-9000 Ext. 9029
Manufacturer 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.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 114 units
Distribution Worldwide and US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OZN and Original Applicant = NANOSPHERE, INC
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