Events

Recall of Device Recall Nanosphere Verigene CYP2C19 Nucleic Acid Test

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
    68710
  • Event Risk Class
    Class 3
  • Event Number
    Z-2559-2014
  • Event Initiated Date
    2014-03-18
  • Event Date Posted
    2014-08-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128490
  • 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
    Drug metabolizing enzyme genotyping systems - Product Code NTI
  • Reason
    Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the verigene cyp2c19 nucleic acid test (2c19), which has been confirmed through internal testing.
  • Action
    Nanosphere sent an Field Notification Letter dated March 18, 2014, 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 products, 2) discard the affected product, and 3) complete and return the attached for to obtain free-of-charge replacement kits. Customers with any questions about this recall should contact their Nanosphere technical support representative at 1 888 837-4436. .

Device

Device Recall Nanosphere Verigene CYP2C19 Nucleic Acid Test
  • Model / Serial
    (Catalog No. 20-005-019)    Kit Numbers (US Distribution): 051013019-9, 6288-1, 6547-1, 6420-1, 5478-1, 5802-1, 6190-1, 7360-3, 5452-2, 6499-1, 6414-1, 7183-1, 7511-1, 5225-1, 5225-2, 6495-1, 5760-1, 5779-1, 7259-1, 6783-1, 7435-1    Kit Numbers (Foreign Distribution): 7300-4, 5500-1, 5908-3, 5970-3, 6402-1, 6402-2, 6105-1, 6123-1, 6793-1, 6827-1, 6224-1
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including the states of AL, CA, MD, ND, NJ, OK and TX., and internationally to Bulgaria, China and New Zealand.
  • Product Description
    Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test.
  • 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