Class 3 Device Recall Nanosphere Verigene

• Date Initiated by Firm: October 16, 2013
• Date Posted: August 08, 2014
• Recall Status: Terminated on May 22, 2015
• Recall Number: Z-2168-2014
• Recall Event ID: 68708
• 510(K)Number: K123197
• Product Classification: C.Difficile toxin gene amplification assay - Product Code OZN
• Product: Nanosphere Verigene ; ; Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. ; ; The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile. The CDF test is indicated for use as an aid in the diagnosis of CDI. Detection of PCR ribotype 027 strains of C. difficile by the CDF test is solely for epidemiological purposes and is not intended to guide or monitor treatment for C. difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.
• Code Information: Verigene CDF Amplification Trays, Catalog Number: 20-011-022, Lot Numbers: 061913022D and 071813022E
• 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 has received report of an increased rate of "No Call - INT CTL 2" results for the Internal Control 2 (INT CTL 2) when negative samples are tested with certain lots of CDF Amplification Trays (20-011-022), which are contained in the CDF Amplification Reagent Kit (20-012-022); specifically for lots 061913022D and 071813022E.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Nanosphere sent an Field Notification Letter dated October 16, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letters included instructions for customers to: 1) discontinue use of the affected product, 2) discard any of the affected product, and 3) complete the attached form and return it to Nanosphere. Customers with questions can contact Nanosphere at 847-400-9000 or 888-837-4436 x 2.
• Quantity in Commerce: 280 sets of trays
• Distribution: US Distribution including the states of CA and WA
• 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 = OZN and Original Applicant = NANOSPHERE, INC