Events

Retiro De Equipo (Recall) de Device Recall Great Basin Staph lD/R Blood Culture Panel

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 Great Basin Scientific, 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
    76076
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1051-2017
  • Fecha de inicio del evento
    2016-12-12
  • Fecha de publicación del evento
    2017-01-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152100
  • 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-positive bacteria and their resistance markers - Product Code PAM
  • Causa
    The great basin staph id/r panel is being recalled because the s. aureus probe could potentially result in a false positive.
  • Acción
    The firm, Great Basin Scientific, notified customers by phone beginning on December 12, 2016 and by email on December 14 and 15, 2016. The notifications described the product, problem and actions to be taken. The customers were instructed to cease using and immediately discard all affected cartridges, the firm will replace those cartridges as soon as possible; and respond to the email or call Direct: 385.219.4540 or Support Team 888.333.9763 or email: customerssupport@gbscience.com with any questions or concerns.

Device

Device Recall Great Basin Staph lD/R Blood Culture Panel
  • Modelo / Serial
    Lot 1629103 Catalog Number: GBSIDR-10 Unique Device ldentifier (UDl): B1 78GBS|DR102
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution.
  • Descripción del producto
    Great Basin Staph lD/R Blood Culture Panel || The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.
  • Manufacturer
    Great Basin Scientific, Inc.

Manufacturer

Great Basin Scientific, Inc.
  • Dirección del fabricante
    Great Basin Scientific, Inc., 2441 S 3850 W, Salt Lake City UT 84120-7209
  • Empresa matriz del fabricante (2017)
    Great Basin Scientific, Inc.
  • Source
    USFDA