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U.S. Department of Health and Human Services

Class 2 Device Recall Nanosphere Verigene

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  Class 2 Device Recall Nanosphere Verigene see related information
Date Initiated by Firm July 09, 2014
Date Posted August 14, 2014
Recall Status1 Terminated 3 on September 01, 2015
Recall Number Z-2236-2014
Recall Event ID 68831
510(K)Number K132843  
Product Classification Gram-Negative bacteria and associated resistance markers - Product Code PEN
Product Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to generate a test result. 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.
Code Information VERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021). TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 042914021B, Expiration Date: 10/26/14
Recalling Firm/
Manufacturer		 Nanosphere, Inc.
4088 Commercial Ave
Northbrook IL 60062-1829
For Additional Information Contact Technical Support
888-837-4436 Ext. 2
Manufacturer Reason
for Recall		 Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs) required for DNA Extraction.
FDA Determined
Cause 2		 Under Investigation by firm
Action Nanosphere sent an Urgent Product Recall letter dated July 9, 2014 to all affected customers. All customers were initially notified of the recall by telephone on July 9, 2014. The customers were instructed to quarantine and return all affected product to Nanosphere. The letter 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 were instructed to contact Nanosphere at 888-837-4436, option 2 or via e-mail at Technicalsupport@nanosphere.us.
Quantity in Commerce 1045 extraction trays (840 affected by recall)
Distribution Nationwide Distribution including CA, CO, IA, MT, OH, OK, OR, TX, and UT
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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