Events

Rappel de Device Recall Janssen Diagnostics, LLC

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 Veridex, LLC.

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
    67447
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1195-2014
  • Date de mise en oeuvre de l'événement
    2014-01-08
  • Date de publication de l'événement
    2014-03-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-07-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125466
  • 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
    System, immunomagnetic, circulating cancer cell, enumeration - Product Code NQI
  • Cause
    Janssen diagnostics, llc received complaints of camera failures on the celltracks analyzer ii¿.
  • Action
    Janssen Diagnostics, LLC sent an Important Product Correction Notification letter dated January 8, 2014 to all affected customers via FedEx overnight courier letter and Foreign Affiliate Consignees by email on January 8, 2014. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Confirmation of Receipt Response form attached. For questions contact Customer Technical Service at 1-877-837-4339.

Device

Device Recall Janssen Diagnostics, LLC
  • Modèle / numéro de série
    First: K050145, cleared 15 March 2005 Latest: K130794, cleared 20 June 2013 9555  Serial numbers:   CT1106005 CT1104002 CT1108006 CT1111009 CT1201001 CT1203004 CT1205011 CT1205012 CT1206013 CT1210022 CT1210024
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide
  • Description du dispositif
    CELLTRACKS ANALYZER II¿ (Product Code 9555) || Product Usage: || The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.
  • Manufacturer
    Veridex, LLC

Manufacturer

Veridex, LLC
  • Adresse du fabricant
    Veridex, LLC, 1001 US Route 202, Raritan NJ 08869-0606
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA