Events

Rappel de Device Recall Oncomine Dx Target Test

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 Life Technologies 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
    79649
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1480-2018
  • Date de mise en oeuvre de l'événement
    2018-02-08
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162895
  • 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
    Next generation sequencing oncology panel, somatic or germline variant detection system - Product Code PQP
  • Cause
    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
  • Modèle / numéro de série
    Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to states: AZ, CA, NC, TX, and VA.
  • Description du dispositif
    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
  • Adresse du fabricant
    Life Technologies Corporation, 7335 Executive Way, Frederick MD 21704-8354
  • Société-mère du fabricant (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA