Events

Retiro De Equipo (Recall) de Nanosphere

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Nanosphere, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    69034
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2682-2014
  • Fecha de inicio del evento
    2013-10-10
  • Fecha de publicación del evento
    2014-09-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-06-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129646
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    C.Difficile toxin gene amplification assay - Product Code OZN
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Product Number: 20-009-022; Lot Number and Expiration Date: Lot: 100313022B, Expiration Date: 04/01/14
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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 strains 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.
  • Manufacturer
    Nanosphere, Inc.

Manufacturer

Nanosphere, Inc.
  • Dirección del fabricante
    Nanosphere, Inc., 4088 Commercial Ave, Northbrook IL 60062-1829
  • Empresa matriz del fabricante (2017)
    Luminex Corporation
  • Source
    USFDA