Class 2 Device Recall Nanosphere

• Date Initiated by Firm: October 10, 2013
• Date Posted: September 23, 2014
• Recall Status: Terminated on June 16, 2015
• Recall Number: Z-2683-2014
• Recall Event ID: 69034
• 510(K)Number: K122514
• Product Classification: Gram-positive bacteria and their resistance markers - Product Code PAM
• Product: The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) 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-UP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria. BC-UP detects and identifies the following bacterial genera and species: Staphylococcus spp., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Enterococcus faecalis, Enterococcus faecium, Streptococcus spp., Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus, group and Listeria spp. In addition, BC-UP detects the mnecA resistance marker, inferring mecA-mediated, methicillin resistance, and the vanA and vanB resistance markers, inferring vanA/vanB-mediated vancomycin resistance. In mixed growth, BC-UP does not specifically attribute van-mediated vancomycin resistance to either E. faecalis or E. faecium, or mecA-mediated methicillin resistance to either S. aureus or S. epidermidis. BC-UP is indicated for use in conjunction with other clinical and laboratory findings to, aid in the diagnosis of bacterial bloodstream infections; however, is not to be used to, monitor these infections. Sub-culturing of positive blood cultures is necessary to recover, organisms for susceptibility testing, identification of organisms not detected by BC-UP, differentiation of mixed growth, association of antimicrobial resistance marker genes to a specific organism, or for epidemiological typing.
• Code Information: Product Number: 20-009-018; Lot Numbers and Expiration Dates: 1) Lot: 090613018B, Expiration Date: 03/05/14; 2) Lot: 091413018B, Expiration Date: 03/13/14; 3) Lot: 091713018C, Expiration Date: 03/16/14; 4) Lot: 091813018B, Expiration Date: 03/17/14; 5) Lot: 092113018C, Expiration Date: 03/20/14; 6) Lot: 100213018B, Expiration Date: 03/31/14
• 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: 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: 4,440 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 = PAM