Events

Rappel de Device Recall Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Illumina Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    69715
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0850-2015
  • Date de mise en oeuvre de l'événement
    2014-11-06
  • Date de publication de l'événement
    2014-12-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-03-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131410
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, cystic fibrosis transmembrane conductance regulator gene, variant gene sequence detection - Product Code PFS
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Instrument Serial No. M70106, M00533L, M70114. Lot No. Shipped: K103313, K103461, K103404, K103487.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US: MD, NY Non-US: France
  • Description du dispositif
    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
  • Manufacturer
    Illumina Inc

Manufacturer

Illumina Inc
  • Adresse du fabricant
    Illumina Inc, 5200 Illumina Way, San Diego CA 92121
  • Société-mère du fabricant (2017)
    Illumina Inc.
  • Source
    USFDA