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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-2023-2023
Recall Event ID 92451
510(K)Number K140083  
Product Classification Gastrointestinal pathogen panel multiplex nucleic acid-based assay system - Product Code PCH
Product Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
Code Information UDI/DI 00840487101568, Lot Numbers: 071322023D, 071822023B, 071822023C, 071922023E, 072022023D, 072622023D, 082422023G, 083022023E, 083122023E, 090622023A, 090822023D, 091322023D, 091422023D, 091422023E, 092022023E, 092122023D, 092722023D, 092822023D, 100422023D, 100722023E, 101422023E, 101822023D, 101822023E, 101922023D, 102022023D, 121322023D, 122722023C, 122722023D, 010323023D, 011323023G, 021323023A, 021323023B, 021523023D, 022123023E, 022323023D, 030123023F, 030223023D, 030223023E, 030623023A, 030823023D, 031623023D
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 3987 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 = PCH and Original Applicant = NANOSPHERE, INC
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