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U.S. Department of Health and Human Services

Class 2 Device Recall Verigene Enteric Pathogens Nucleic Acid Test (EP)

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 Class 2 Device Recall Verigene Enteric Pathogens Nucleic Acid Test (EP)see related information
Date Initiated by FirmMay 08, 2018
Create DateOctober 11, 2018
Recall Status1 Terminated 3 on June 29, 2020
Recall NumberZ-2952-2018
Recall Event ID 80517
510(K)NumberK142033 
Product Classification Gastrointestinal pathogen panel multiplex nucleic acid-based assay system - Product Code PCH
ProductVerigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
Code Information Catalog number 20-005-023;  Cartridge Catalog number 20-006-023;  Lot 032718023A;  UDI 00857573006041 
Recalling Firm/
Manufacturer		 Luminex Corporation
12212 Technology Blvd
Austin TX 78727-6101
For Additional Information Contact
512-219-8020 Ext. 202
Manufacturer Reason
for Recall		Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nucleic Acid Test Cartridges component (20-006-023) from the Verigene EP Nucleic Acid Test Kit (20-005-023).
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm notified customers on or about 05/08/2018 via a letter entitled "URGENT: MEDICAL DEVICE RECALL". The Luminex informed the customer reason why they are receiving a recall notice---elevated false positive Yersinia enterocolitica (Yersinia) results when using the EP Nucleic Acid Test Cartridges component (20-006-023) from the Verigene EP Nucleic Acid Test Kit (20-005-023). The letter described the intended use of the test kit and the distribution dates. The letter provided instructions for destroying the product if found in the inventory by a customer at a customer site. Luminex advised the customer to complete and return an enclosed Acknowledgment and Receipt form whether a customer had a recalled product on site or not. Luminex Technical Support are available assist in completing this form. Luminex Customer Experience Team contact information is as follows: 1-877-785-2323 (U.S. and Canada) (24 hours/7days) +1-512-381-4397 (Outside U.S. and Canada) (24 hours/7days) support@luminexcorp.com
Quantity in Commerce790 Cartridge Carriers containing 3160 Cartridges
DistributionDomestic Distribution: Arizona, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, New Hampshire, Tennessee, Texas, Utah, West Virginia, Wisconsin.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = PCH
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