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U.S. Department of Health and Human Services

Class 2 Device Recall Verigene BCGP Nucleic Acid Test

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 Class 2 Device Recall Verigene BCGP Nucleic Acid Testsee related information
Date Initiated by FirmJune 20, 2024
Date PostedAugust 08, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2533-2024
Recall Event ID 94970
510(K)NumberK122514 
Product Classification Gram-positive bacteria and their resistance markers - Product Code PAM
ProductVerigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Code Information GTIN Number: 00840487101575; Catalog Number: 20-006-018; Lot Number: 031824018A; Expiration Date: 09/16/2024
Recalling Firm/
Manufacturer		 Luminex Corporation
4088 Commercial Ave
Northbrook IL 60062-1829
For Additional Information ContactLuminex Technical Support
877-785-2323 Ext. 9029
Manufacturer Reason
for Recall		Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
FDA Determined
Cause 2		Under Investigation by firm
ActionDiasorin sent a recall notification on 06/20/2024, via email. Consignees were instructed to examine inventory and quarantine any affected units, arrange for replacement and confirm disposal of any of affected units on hand. Customers were asked to perform a retrospective review of results for VERIGENE Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) to look for any false positives, distribute the notification to any relevant personnel, notify consignees if further distributed and complete and return the "Acknowledgement & Receipt Form."
Quantity in Commerce1,100 kits
DistributionUS Nationwide distribution including in the states of AZ, CA, CO, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, MS, NE, NV, OH, OK, SC, TN, TX, VA, VT, WA, WV.
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 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) Database510(K)s with Product Code = PAM
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