Events

Retiro De Equipo (Recall) de Device Recall MiSeqDx Universal Kit 1.0

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
    69766
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0849-2015
  • Fecha de inicio del evento
    2014-11-13
  • Fecha de publicación del evento
    2014-12-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131490
  • 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
    Reagents for molecular diagnostic test systems - Product Code PFS
  • Causa
    It was discovered a software limitation with miseq reporter software (version 2.2.31) when using the miseqdx universal kit 1.0 on the miseqdx instrument. the software cannot report insertions or deletions at specific genomic locations with respect to the primer.
  • Acción
    A customer letter dated November 13, 2014, was sent to all customers who is using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The letter informs the customers that Illumina has recently confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot report insertions or deletions at specific genomic locations with respect to the primer. The customer notification outlines the potential issues, the results of investigation, actions required, and next steps. Customers are instructed to return the attached Verification form to confirm their receipt of the letter and document the results of any patient impact from the limitation. 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. For further questions, please call (858) 736-3861.

Device

Device Recall MiSeqDx Universal Kit 1.0
  • Modelo / Serial
    Serial No. M70130, M70189, M70108, M70165, M70166, M70175, M70172, M70103.
  • Clasificación del producto
    Hematology and Pathology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.
  • Descripción del producto
    Illumina MiSeqDx Universal Kit 1.0, PN 15039608 || The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx instrument.
  • 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