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U.S. Department of Health and Human Services

Class 3 Device Recall Vergene GramPositive Blood Culture Nucleic Acid Test (BCGP)

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  Class 3 Device Recall Vergene GramPositive Blood Culture Nucleic Acid Test (BCGP) see related information
Date Initiated by Firm December 26, 2018
Create Date February 11, 2019
Recall Status1 Open3, Classified
Recall Number Z-0822-2019
Recall Event ID 81890
510(K)Number K122514  
Product Classification Gram-positive bacteria and their resistance markers - Product Code PAM
Product Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018

The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-GP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria.
Code Information UDI: 00857573006287, Lots: 110318018C, 111018018D
Recalling Firm/
Manufacturer
Luminex Corporation
12212 Technology Blvd
Austin TX 78727-6101
For Additional Information Contact Luminex Global Support
877-785-2323
Manufacturer Reason
for Recall
On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
FDA Determined
Cause 2
Under Investigation by firm
Action The firm, Luminex, notified the consignees by email with a letter entitled "URGENT: MEDICAL DEVICE RECALL" dated 12/20/2018 on 12/26/2018. The letter described the product, problem and actions to be taken. The customers were instructed to: Please check your VERIGENE¿ BC-GP Utility Kit inventory to determine if you have any of the listed products; if product(s) is (are) located within your inventory, please follow the instructions and information about destroying any found recalled product at your facility, and complete and return Acknowledgment and Receipt form an email, and send it on or before January 15, 2019 to support@luminexcorp.com or by mail to: Luminex Corporation Attn: Global Support Services 12201 Technology Boulevard Suite 130 Austin, TX 78727 The firm expanded the recall to include one new lot and notified the consignees on 01/17/2019. This lot was to be destroyed. Please call the Luminex-Global Support Services with any questions or concerns at 1-877-785-2323 (U.S. and Canada) (24 hours/7days); +1-512-381-4397 (Outside U.S. and Canada) (24 hours/7days) or email support@luminexcorp.com.
Quantity in Commerce 1132 carriers
Distribution Worldwide Distribution: US (nationwide) and countries of: Austria, Japan, and Italy.
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 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) Database 510(K)s with Product Code = PAM and Original Applicant = NANOSPHERE, INC
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