Events

Rappel de QMS Everolimus Assay

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 Microgenics Corporation.

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
    74982
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0008-2017
  • Date de mise en oeuvre de l'événement
    2016-08-15
  • Date de publication de l'événement
    2016-10-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148982
  • 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
    Everolimus immunoassay - Product Code OUF
  • Cause
    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
  • Modèle / numéro de série
    Lot number: 72258049, Expiry date: 07/31/2017; Lot number: 72258007, Expiry date 07/31/2017.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Microgenics Corporation, 46500 Kato Rd, Fremont CA 94538-7310
  • Société-mère du fabricant (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA