Events

Recall of Device Recall Nanosphere Verigene GramNegative Blood Culture Nucleic Acid Test (BCGN)

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
    68014
  • Event Risk Class
    Class 2
  • Event Number
    Z-2736-2014
  • Event Initiated Date
    2013-06-17
  • Event Date Posted
    2014-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128491
  • 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
    Gram-Negative bacteria and associated resistance markers - Product Code PEN
  • Reason
    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.
  • 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.

Device

Device Recall Nanosphere Verigene GramNegative Blood Culture Nucleic Acid Test (BCGN)
  • Model / Serial
    Part Number: 20-009-021; Lot Numbers: 052113021C
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN 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.
  • Manufacturer
    Nanosphere, Inc.

Manufacturer

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