Events

Retiro De Equipo (Recall) de Verigene GramNegative Blood Culture Nucleic Acid Test (BCGN)

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
    68177
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2170-2014
  • Fecha de inicio del evento
    2014-04-17
  • Fecha de publicación del evento
    2014-08-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127104
  • 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
    Gram-Negative bacteria and associated resistance markers - Product Code PEN
  • Causa
    Nanosphere has determined that a portion of bc-gn test cartridge lot number 040214021a has an elevated risk for no call results and false negative results. the bc-gn test cartridge (20-006-021) is distributed as part of the verigene bc-gn test kit (20-005-021), which is labeled as "ivd". therefore, nanosphere has initiated a voluntary recall to retrieve the following bc-gn test cartridges: test ca.
  • Acción
    All customers were initially notified of the recall by telephone on April 17, 2014. The customers were instructed to quarantine and return all affected product to Nanosphere. Nanosphere sent an Voluntary Product Recall Notification letter dated April 17, 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: 1) on how to return the recalled products, and 2) to review any test results that were generated while using the recalled products to ensure that there has been no negative impact on patient care. Customers with questions can contact Nanosphere at 888-837-4436, option 2 or via e-mail at Technicalsupport@nanosphere.us..

Device

Verigene GramNegative Blood Culture Nucleic Acid Test (BCGN)
  • Modelo / Serial
    VERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021).   TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 040214021A, Cartridge Numbers: 02148613 - 02148832, Expiration Date: 9/29/14
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution including the states of AZ, CA, FL, MN, MT, NE, NJ, NY, TX and WI
  • Descripción del producto
    Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-negative bacteria as determined by gram stain. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by BC-GN, to detect mixed infections that may not be detected by BC-GN, for association of antimicrobial resistance marker genes to a specific organisms, or for epidemiological typing. The BC-GN test is performed on the Verigene System platform, which is a fully automated, bench-top, molecular diagnostics workstation consisting of Verigene Reader and a bank of up to 32 Verigene Processor SP units. The System enables the detection of bacterial DNA from blood culture, unformed stool, or nasopharyngeal swab, depending on the test, through automated nucleic acid extraction and hybridization.
  • 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