Events

Recall of Device Recall Oncomine Dx Target Test

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

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
    79437
  • Event Risk Class
    Class 2
  • Event Number
    Z-1279-2018
  • Event Initiated Date
    2017-12-04
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162327
  • 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
    Next generation sequencing oncology panel, somatic or germline variant detection system - Product Code PQP
  • Reason
    The oncomine dx target test may report erroneous results when used off-label for samples other than non-small cell lung cancer (nsclc) tumor specimens.
  • Action
    The following actions are described in the consignee later: Review your testing results from the Oncomine Dx Target Test to ensure that none of the reports containing BRAF V600E positive samples are impacted. Utilize Figure 1 and 2 to aid in identifying this discrepancy. If you have any questions, please contact 408.802.2341.

Device

Device Recall Oncomine Dx Target Test
  • Model / Serial
    Lot Numbers: v1.8 (Rev. C) (REVC20170906) and v1.8 (Rev. C) (REVC27JUN2017)  UDI: (01)10190302006071
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of: AZ, CA, NC, TX, and VA.
  • Product Description
    Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 || The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to detect single-nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.
  • Manufacturer
    Life Technologies Corporation

Manufacturer

Life Technologies Corporation
  • Manufacturer Address
    Life Technologies Corporation, 7335 Executive Way, Frederick MD 21704-8354
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA