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
    79649
  • Event Risk Class
    Class 2
  • Event Number
    Z-1480-2018
  • Event Initiated Date
    2018-02-08
  • 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=162895
  • 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 lower concentration of the rna panel could cause a no call or false negative for the reporting of ros1 fusion. if a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.
  • Action
    The firm issued an Urgent: Medical Device Recall Notification, dated February 16, 2018, via e-mail and phone call to affected consignees. The letter identified the affected device and advised customers of the potential "No Call" or false positive outcomes. Users were advised that they may need an alternate method to determine the presence of ROS1 variant in previously tested patient samples, and that any future tests using the affected lot cannot be considered valid if "No Call" or "Negative" is the result. Requested action included reviewing previous results which used the affected lot. Customers are to complete the Customer Response Sheet provided and e-mail a scanned copy along with the letter to vineet.bansal1@thermofisher.com. Questions and comments should be directed to Vineet Bansal, 408-802-2341, vineet.bansal1@thermofisher.com.

Device

Device Recall Oncomine Dx Target Test
  • Model / Serial
    Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Distributed to states: AZ, CA, NC, TX, and VA.
  • Product Description
    Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). || A qualitative In Vitro Diagnostic test.
  • 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