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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 Firm September 14, 2018
Date Posted November 10, 2018
Recall Status1 Terminated 3 on April 28, 2021
Recall Number Z-0445-2019
Recall Event ID 81220
510(K)Number K122514  
Product Classification Gram-positive bacteria and their resistance markers - Product Code PAM
Product VERIGENE 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 Contact Ronald Dunn
512-249-4727
Manufacturer Reason
for Recall		 Potential to lead to a false negative results.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 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 Commerce 12,700 trays
Distribution Worldwide 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 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PAM and Original Applicant = NANOSPHERE, INC
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