Events

Recall of Device Recall Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Illumina Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69715
  • Event Risk Class
    Class 3
  • Event Number
    Z-0850-2015
  • Event Initiated Date
    2014-11-06
  • Event Date Posted
    2014-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131410
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, cystic fibrosis transmembrane conductance regulator gene, variant gene sequence detection - Product Code PFS
  • Reason
    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
  • Model / Serial
    Instrument Serial No. M70106, M00533L, M70114. Lot No. Shipped: K103313, K103461, K103404, K103487.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US: MD, NY Non-US: France
  • Product Description
    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
  • Manufacturer
    Illumina Inc

Manufacturer

Illumina Inc
  • Manufacturer Address
    Illumina Inc, 5200 Illumina Way, San Diego CA 92121
  • Manufacturer Parent Company (2017)
    Illumina Inc.
  • Source
    USFDA