Events

Recall of QMS Everolimus Assay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Microgenics 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
    74982
  • Event Risk Class
    Class 2
  • Event Number
    Z-0008-2017
  • Event Initiated Date
    2016-08-15
  • Event Date Posted
    2016-10-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148982
  • 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
    Everolimus immunoassay - Product Code OUF
  • Reason
    A reagent stability issue (still under investigation) causes less separation in the calibration curve, which affects results across the entire range. for controls, maximum bias of +/- 35% for low levels, +/- 33% for mid-range levels, and +/- 47% for high levels is observed. bias in patient samples ranges from -15.7% to +5.2% with an average bias of -5.6% when comparing the qms everolimus assay to an everolimus lc-ms reference method. patient samples across the measuring range  sub-therapeutic, therapeutic, and supra-therapeutic  could be affected.
  • Action
    Thermo Fisher sent an Urgent Medical Device Field Action letter dated on August 15, 2016 to customers via regular mail. The letter identified the affected product, problem and actions to be taken. Customers are advised to Discontinue use and destroy any remaining inventory of the affected lots per your local waste ordinances. Customers were instructed to cmplete the attached Medical Device Field Action Response Form and return the form to Thermo Fisher Scientific Technical Service. For questions contact Technical Service at 1-800-232-3342 (USA only) or 510-979-5000 (outside the USA) then press option 2, then option 3.

Device

QMS Everolimus Assay
  • Model / Serial
    Lot number: 72258049, Expiry date: 07/31/2017; Lot number: 72258007, Expiry date 07/31/2017.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of KY, CA, NY, DC, NC, TX, IL, OH, IL, FL, IK, IA, MS and countries of Mexico, Taiwan, Guatemala, Malaysia, Argentina, Dominican Republic, Philippines, Germany, Australia.
  • Product Description
    Thermo Scientific QMS Everolimus Assay; || Model number: || 0380000 (US Distribution); || 0373852 (Foreign Distribution) || Product Usage: || The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS Everolimus assay is intended to be used as an aid in the management of patients receiving everolimus therapy for those organ transplant procedures indicated in the chart for each specific country.
  • Manufacturer
    Microgenics Corporation

Manufacturer

Microgenics Corporation
  • Manufacturer Address
    Microgenics Corporation, 46500 Kato Rd, Fremont CA 94538-7310
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA