Events

Rappel de Device Recall MiSeqDx Universal Kit 1.0

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
    69766
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0849-2015
  • Date de mise en oeuvre de l'événement
    2014-11-13
  • 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
    2015-03-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131490
  • 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
    Reagents for molecular diagnostic test systems - Product Code PFS
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Serial No. M70130, M70189, M70108, M70165, M70166, M70175, M70172, M70103.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.
  • Description du dispositif
    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
  • Adresse du fabricant
    Illumina Inc, 5200 Illumina Way, San Diego CA 92121
  • Société-mère du fabricant (2017)
    Illumina Inc.
  • Source
    USFDA