Events

Retiro De Equipo (Recall) de Device Recall Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay

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 Illumina 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
    69715
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0850-2015
  • Fecha de inicio del evento
    2014-11-06
  • Fecha de publicación del evento
    2014-12-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131410
  • 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
    System, cystic fibrosis transmembrane conductance regulator gene, variant gene sequence detection - Product Code PFS
  • Causa
    Illumina has confirmed a software limitation with miseq reporter software (version 2.2.31) when using the miseqdx cystic fibrosis clinical sequencing assay on the miseqdx instrument.
  • Acción
    A customer notification letter dated 11/12/14 was sent to all customers who purchased the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay. The letter confirms that there is a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument. At certain genomic locations within the region sequenced by the assay, deletions cannot be reported by the software. The letter outlines the potential issues, the results of Illuminia's investigation, and the firm's next steps. Customers' with technical questions or concerns, are instructed to contact their local support team or Illumina Technical Support at techsupport@illumina.com. Customers with questions regarding the field action, are instructed to contact Illumina Regulatory Affairs at RA@illumina.com. Customers will be contacted by 11/13/14 by phone and a phone script was provided that includes the procedure, talking points, actions required, and next steps.

Device

Device Recall Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay
  • Modelo / Serial
    Instrument Serial No. M70106, M00533L, M70114. Lot No. Shipped: K103313, K103461, K103404, K103487.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US: MD, NY Non-US: France
  • Descripción del producto
    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
  • Manufacturer
    Illumina Inc

Manufacturer

Illumina Inc
  • Dirección del fabricante
    Illumina Inc, 5200 Illumina Way, San Diego CA 92121
  • Empresa matriz del fabricante (2017)
    Illumina Inc.
  • Source
    USFDA