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U.S. Department of Health and Human Services

Class 2 Device Recall VERIGENE

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 Class 2 Device Recall VERIGENEsee related information
Date Initiated by FirmApril 16, 2025
Date PostedJune 03, 2025
Recall Status1 Completed
Recall NumberZ-1903-2025
Recall Event ID 96701
510(K)NumberK132843 
Product Classification Gram-Negative bacteria and associated resistance markers - Product Code PEN
ProductVERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
Code Information UDI/DI 00840487101599, Lot Number 022525021A, exp. 08/26/2025
FEI Number 3006028115
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 was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
FDA Determined
Cause 2		Under Investigation by firm
ActionDiasorin issued an Urgent Field Safety Notice to its consignees on 04/16/2025 via email. The notice explained the issue, potential risk to health, and requested the following: "Actions to be taken by the Customer/User 1. Please examine your inventory for the affected products, cease all use, and isolate or quarantine them pending disposal. 2. If you currently have any of the identified affected barcode serial numbers from VERIGENE BC-GN Nucleic Acid Test Cartridge, Lot 022525021A, please contact Technical Support at support@luminexcorp.com to arrange for replacement and confirm the disposal of any remaining tests in your inventory per the package insert disposal guidelines. 3. Perform a retrospective review of results for VERIGENE Gram-Negative Blood Culture Nucleic Acid Test (BC-GN). If you have encountered a false negative result with a patient sample tested with the potentially impacted portion of Lot 022525021A, please contact Technical Support at support@luminexcorp.com. 5. If you are a distributor, provide a copy of this letter to any customers or organizations who may have received VERIGENE BC-GN Nucleic Acid Test Cartridge, Lot 022525021A. 6. Please complete the Acknowledgement & Receipt Form and return it to Technical Support. 7. For those with complaints, questions, or concerns please contact Technical Support at 1-877-785-2323 (U.S) or +1-512-381-4397 (Outside U.S.)."
Quantity in Commerce89 units
DistributionUS Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.
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.
510(K) Database510(K)s with Product Code = PEN
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