Class 2 Device Recall Luminex Verigene

• Date Initiated by Firm: June 05, 2023
• Date Posted: June 28, 2023
• Recall Status: Open, 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: 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