Events

Recall of Device Recall Verigene Warfarin Metabolism Nucleic Acid Test Cartridge

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
    46882
  • Event Risk Class
    Class 2
  • Event Number
    Z-1383-2008
  • Event Initiated Date
    2008-02-25
  • Event Date Posted
    2008-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68369
  • 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
    Verigene Warfarin Metabolism Nucleic Acid Test Cartridge - Product Code ODW
  • Reason
    Aberrant results: a warfarin 2c9*2 mutant capture signal was found to be high enough to result in an aberrant result (i.E., wild-type called heterozygous).
  • Action
    Nanosphere sent Urgent Device Recall letters dated 2/25/08 to the direct accounts on the same date, informing them of the potential for aberrant results with the use of the affected lots of cartridges. The accounts were requested to examine their stocks for the affected lots of cartridges, segregate those found and return them to Nanosphere for replacement. Any questions can be directed to Dr. Gregg Shipp at 847-400-9115.

Device

Device Recall Verigene Warfarin Metabolism Nucleic Acid Test Cartridge
  • Model / Serial
    Lot Numbers 121907002B, 010708002A, 012108002A, 012108002C, 012208002C, 012408002B, 012808002A, and 020608002A
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide; USA including states of Kentucky, Michigan, Tennessee, Texas, Louisiana, Connecticut, Illinois, and California.
  • Product Description
    Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diagnostic drug metabolizing enzyme genotyping system; Nanosphere, Inc., 4088 Commercial Ave., Northbrook, IL 60062
  • 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