Events

Rappel de Veridex

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
    38206
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1102-2007
  • Date de mise en oeuvre de l'événement
    2007-04-17
  • Date de publication de l'événement
    2007-07-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-12-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53161
  • 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
    in vitro diagnostic - Product Code NQI
  • Cause
    An increased incidence of aggregates was observed in lot 0036 and 0036a. the presence of aggregates will cause customers to invalidate patient results.
  • Action
    All Direct customers and customers of distributors received a customer notification informing them of the increased incidence of aggregates in cartridges on April 30, 2007 by Fed Ex overnight. This letter instructed them to discontinue use and to discard any remaining inventory. This was followed by a notification on May 24, 2007 by Fed Ex overnight to all US Distributors which also requested that they immediately stop using and/or distributing kits and to destroy any remaining inventory. Distributors were also asked to notifiy customers who received product. All foreign affiliate consignees were also informed on this date by e-mail and instructed to notify their customers.

Device

Veridex
  • Modèle / numéro de série
    Ref 7900001, Lot 0036 Ref 7900000, Lot 0036A - This is a research use only lot and not for in vitro diagnostic use.
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The kits were distributed to hospitals and laboratories nationwide. They were also sent to 7 J&J; affiliated companies in France, Japan, Canada, England, Germany, Italy and Spain.
  • Description du dispositif
    Cell Search Circulating Tumor Cell Kit (Epithelial) || Veridex LLC, a Johnson & Johnson Company || IVD || Veridex, LLC || 33 Technology Drive || Warren, NJ 07059 USA || 1-877-VERIDEX USA
  • Manufacturer
    Veridex, LLC

Manufacturer

Veridex, LLC
  • Adresse du fabricant
    Veridex, LLC, 33 Technology Dr, Warren NJ 07059-5148
  • Source
    USFDA