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Class 2 Device Recall The Verigene GramPositive Blood Culture Nucleic Acid Test (BCGP) |
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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
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Product Classification |
Gram-positive bacteria and their resistance markers - Product Code PAM
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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.
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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
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For Additional Information Contact |
Ronald Dunn 512-249-4727
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Manufacturer Reason for Recall |
Potential to lead to a false negative results.
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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
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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.
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510(K) Database |
510(K)s with Product Code = PAM and Original Applicant = NANOSPHERE, INC
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