Events

Recall of Nanosphere

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
    69034
  • Event Risk Class
    Class 2
  • Event Number
    Z-2685-2014
  • Event Initiated Date
    2013-10-10
  • Event Date Posted
    2014-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129649
  • 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
    Gastrointestinal pathogen panel multiplex nucleic acid-based assay system - Product Code PCH
  • Reason
    Nanosphere has received several reports relating to an increased rate of processing errors during procedures performed on the processor sp caused by tips in tip holder assemblies for the following products and lots of extraction trays.
  • Action
    Nanosphere sent a Field Notification Letter dated October 10, 2013, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Instructions were included in the letter for customers to determine whether or not the extraction tray lots should be returned. If the extraction tray lots are to be returned, customers were to complete and return the attached form and replacement tip holder assemblies will be supplied at no cost. Customers could then dispose of the recalled unused tip holder assemblies. Customers with questions were instructed to contact their Nanosphere technical support representative. For questions regarding this recall call 1-888-837-4436, ext 3.

Device

Nanosphere
  • Model / Serial
    Product Number: (Not Applicable); Lot Numbers and Expiration Dates: 1) Lot: 091313023CIUO, Expiration Date: 03/12/14; 2) Lot 092713023CIUO, Expiration Date: 03/26/14
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OR, PA, TX, UT, VA, WA, WI, OH and Internationally to Bulgaria, Germany, Italy, Japan, South Korea, and Spain.
  • Product Description
    The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated Nanosphere Verigene System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the following pathogenic bacteria: || - Campylobacter Group (comprised of C. coli, C. jejuni, and C. lari), || - Salmonella species, || - Shigella species (including S. dysenteriae, S. boydii, S. sonnei, and S. flexneri), || - Vibrio Group (comprised of V. cholerae and V. parahaemolyticus), || - Yersinia enterocolitica. || In addition, EP detects the Shiga toxin 1 gene and Shiga toxin 2 gene virulence markers. Shiga toxin producing E. coli (STEC) typically harbor one or both genes that encode for Shiga Toxins 1 and 2. || EP is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological information; however, is not to be used to monitor these infections. EP also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. || Due to the limited number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Yersinia enterocolitica, Vibrio Group and Shigella species were primarily established with contrived specimens. || Concomitant culture is necessary for organism recovery and further typing of bacterial agents. || EP results should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative EP results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.
  • 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