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U.S. Department of Health and Human Services

Class 2 Device Recall The Verigene GramPositive Blood Culture Nucleic Acid Test (BCGP)

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 Class 2 Device Recall The Verigene GramPositive Blood Culture Nucleic Acid Test (BCGP)see related information
Date Initiated by FirmSeptember 14, 2018
Date PostedNovember 10, 2018
Recall Status1 Terminated 3 on April 28, 2021
Recall NumberZ-0445-2019
Recall Event ID 81220
510(K)NumberK122514 
Product Classification Gram-positive bacteria and their resistance markers - Product Code PAM
ProductVERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.
Code Information Supplier raw tray lots 195916-070518 and 190943-073118 Utility Tray Lots: 082518018C, 081618018C, 082918018C, 090418018B, 081118018C and 082718018B 
Recalling Firm/
Manufacturer		 Luminex Corporation
12212 Technology Blvd
Austin TX 78727-6101
For Additional Information ContactRonald Dunn
512-249-4727
Manufacturer Reason
for Recall		Potential to lead to a false negative results.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn September14, 2018, Luminex sent Urgent Customer Advisory Notifications to their consignees. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Experience Team.
Quantity in Commerce12,700 trays
DistributionWorldwide Distribution - US Nationwide in the states of United States - AZ, CA, CO, CT, DC, FL, GA,, IA, ID, IN, KA,, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NV, NJ, NY, OK,,OH, OR, PA, SC, TN, TX, UT, VT, WA, KS, and VA.. France
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 = PAM
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