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U.S. Department of Health and Human Services

Class 2 Device Recall Nanosphere

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  Class 2 Device Recall Nanosphere see related information
Date Initiated by Firm October 10, 2013
Date Posted September 23, 2014
Recall Status1 Terminated 3 on June 16, 2015
Recall Number Z-2681-2014
Recall Event ID 69034
510(K)Number K132843  
Product Classification Gram-Negative bacteria and associated resistance markers - Product Code PEN
Product The 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.
Code Information Product Number: 20-009-021; Lot Number and Expiration Date: Lot: 100113021C, Expiration Date: 03/30/14
Recalling Firm/
Manufacturer		 Nanosphere, Inc.
4088 Commercial Ave
Northbrook IL 60062-1829
For Additional Information Contact Customer Support
888-837-4436 Ext. 3
Manufacturer Reason
for Recall		 Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Nanosphere sent a Field Notification Letter dated October 10, 2013, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Instructions were included in the letter for customers to determine whether or not the extraction tray lots should be returned. If the extraction tray lots are to be returned, customers were to complete and return the attached form and replacement tip holder assemblies will be supplied at no cost. Customers could then dispose of the recalled unused tip holder assemblies. Customers with questions were instructed to contact their Nanosphere technical support representative. For questions regarding this recall call 1-888-837-4436, ext 3.
Quantity in Commerce 400 units
Distribution Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA, TX, UT, VA, WA, WI, OH and Internationally to Bulgaria, Germany, Italy, Japan, South Korea, and Spain.
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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