Events

Rappel de Device Recall Benchmark & Discovery

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 Ventana Medical Systems Inc.

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
    49516
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2118-2013
  • Date de mise en oeuvre de l'événement
    2008-06-12
  • Date de publication de l'événement
    2013-08-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73710
  • 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
    Slide stainer, automated - Product Code KPA
  • Cause
    Ventana medical system is initiating the recall of the benchmark and discovery series instruments because there is a possibility that the heating element could separate from the underside of the heater cap and cause a non-staining or inconsistent staining event. additionally, the system may not detect this anomaly and therefore it may not generate an error message for the slide position.
  • Action
    Ventana sent an Urgent Medical Device Correction Notification letter dated June 16, 2008 to all affected customers. The letter identifed the affected product, problem and actions to be taken. The letter instructed customers to carefully read and perform all of the actions outlined in the notification letter concerning potential safety issue. Customers with concerns regarding the staining results on any patient specimen are instructed to follow their internal Quality Procedures regarding the review of patient reports. For question contact your local Customer Service Center.

Device

Device Recall Benchmark & Discovery
  • Modèle / numéro de série
    BenchMark XT Instruments-S/N: 711869-712465; BenchMark LT instruments-S/N: 610321-610345. Discovery XT Instruments-S/N: 610321-610345.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the countries of Canada, Europe, Asia, Japan.
  • Description du dispositif
    Benchmark XT/LT and Discovery XT || Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. || Product Usage: Usage: || The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ hybridization reagents for in vitro diagnostic use. The Discovery Systems are research use only instruments with similar functionality.
  • Manufacturer
    Ventana Medical Systems Inc

Manufacturer

Ventana Medical Systems Inc
  • Adresse du fabricant
    Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Tucson AZ 85755
  • Société-mère du fabricant (2017)
    Roche Holding Ag
  • Source
    USFDA