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U.S. Department of Health and Human Services

Class 2 Device Recall Verigene GramNegative Blood Culture Nucleic Acid Test (BCGN)

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  Class 2 Device Recall Verigene GramNegative Blood Culture Nucleic Acid Test (BCGN) see related information
Date Initiated by Firm April 17, 2014
Date Posted August 08, 2014
Recall Status1 Terminated 3 on March 14, 2016
Recall Number Z-2170-2014
Recall Event ID 68177
510(K)Number K132843  
Product Classification Gram-Negative bacteria and associated resistance markers - Product Code PEN
Product Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-negative bacteria as determined by gram stain. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by BC-GN, to detect mixed infections that may not be detected by BC-GN, for association of antimicrobial resistance marker genes to a specific organisms, or for epidemiological typing. The BC-GN test is performed on the Verigene System platform, which is a fully automated, bench-top, molecular diagnostics workstation consisting of Verigene Reader and a bank of up to 32 Verigene Processor SP units. The System enables the detection of bacterial DNA from blood culture, unformed stool, or nasopharyngeal swab, depending on the test, through automated nucleic acid extraction and hybridization.
Code Information VERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021).   TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 040214021A, Cartridge Numbers: 02148613 - 02148832, Expiration Date: 9/29/14
Recalling Firm/
Manufacturer		 Nanosphere, Inc.
4088 Commercial Ave
Northbrook IL 60062-1829
For Additional Information Contact Ms. Lindsey Saxon
847-400-9173
Manufacturer Reason
for Recall		 Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an elevated risk for No Call results and False Negative results. The BC-GN Test Cartridge (20-006-021) is distributed as part of the Verigene BC-GN Test Kit (20-005-021), which is labeled as "IVD". Therefore, Nanosphere has initiated a voluntary recall to retrieve the following BC-GN Test Cartridges: Test Ca
FDA Determined
Cause 2		 Under Investigation by firm
Action All customers were initially notified of the recall by telephone on April 17, 2014. The customers were instructed to quarantine and return all affected product to Nanosphere. Nanosphere sent an Voluntary Product Recall Notification letter dated April 17, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letters included instructions: 1) on how to return the recalled products, and 2) to review any test results that were generated while using the recalled products to ensure that there has been no negative impact on patient care. Customers with questions can contact Nanosphere at 888-837-4436, option 2 or via e-mail at Technicalsupport@nanosphere.us..
Quantity in Commerce 580 test cartridges
Distribution US Distribution including the states of AZ, CA, FL, MN, MT, NE, NJ, NY, TX and WI
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 = PEN and Original Applicant = NANOSPHERE, INC
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