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
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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
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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 |
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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 = PEN
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