Class 2 Device Recall Verigene GramPositive Blood Culture Nucleic Acid Test (BCGP)

• Date Initiated by Firm: June 17, 2013
• Date Posted: September 30, 2014
• Recall Status: Terminated on March 14, 2016
• Recall Number: Z-2735-2014
• Recall Event ID: 68014
• 510(K)Number: K122514
• Product Classification: Gram-positive bacteria and their resistance markers - Product Code PAM
• Product: Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.
• Code Information: Part Number: 20-009-018; Lot Numbers: 051713018B, 052413018C
• Recalling Firm/ Manufacturer: Nanosphere, Inc.; 4088 Commercial Ave; Northbrook IL 60062-1829
• For Additional Information Contact: 847-400-9115
• Manufacturer Reason for Recall: There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.
• FDA Determined Cause: Process change control
• Action: Undated recall notification letters were sent to all direct accounts (customers) June 17 - 19, 2013. The letters included instructions for customers to: 1) check their inventory for the recalled products; 2) set any recalled products aside for return; and, 3) contact Nanosphere to obtain replacement tip holders. Customers with questions about this recall can contact Nanosphere via e-mail at technicalsupport@nanosphere.us or by calling 888-837-4436.
• Quantity in Commerce: 1,660 extraction trays
• Distribution: Worldwide Distribution:US (Nationwide) including states of: AZ, CA, FL, IL, KY, MD, MN, MT, OH, PA, TN, TX, VA, WA, WI; and countries of: Belgium, China, and Saudi Arabia.
• 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