Recall of Nanosphere Verigene

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nanosphere, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68708
  • Event Risk Class
    Class 3
  • Event Number
    Z-2168-2014
  • Event Initiated Date
    2013-10-16
  • Event Date Posted
    2014-08-08
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2015-05-22
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    C.Difficile toxin gene amplification assay - Product Code OZN
  • Reason
    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.
  • 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.

Device

  • Model / Serial
    Verigene CDF Amplification Trays, Catalog Number: 20-011-022, Lot Numbers: 061913022D and 071813022E
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of CA and WA
  • Product Description
    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.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Nanosphere, Inc., 4088 Commercial Ave, Northbrook IL 60062-1829
  • Manufacturer Parent Company (2017)
  • Source
    USFDA