Events

Rappel de EnVision FLEX, EnVision FLEX, EnVision FLEX Mini Kit

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 Dako North America 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
    72097
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0220-2016
  • Date de mise en oeuvre de l'événement
    2015-09-04
  • Date de publication de l'événement
    2015-11-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-04-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139936
  • 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
    Reagent, general purpose - Product Code LDT
  • Cause
    There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results.
  • Action
    Dako sent an customer notification letter on September 4, 2015, to all affected customers via mail. The letter identified the product the problem and the action needed to be taken by the customer. The customers/distributors are instructed in the Recall Notification Letters to 1) remove any unused kits bearing the affected lot numbers listed in their letter from diagnostic use 2) destroy any unused kits bearing the affect lot numbers listed in their letter, and 3) determine any possible impact of this change in performance on patient results from the affected lots. The letter states actions should be taken within 10 days and that customers/distributors should confirm they have received the information by returning the attached, fully completed Device Recall Form and return it to Dako QA Vigilance by email at dako.dkvigilance@dako.com. The firm lists on their letter for customers to contact their Dako representative in there are any questions. For further questions, call (805) 566-6655.

Device

EnVision FLEX, EnVision FLEX, EnVision FLEX Mini Kit
  • Modèle / numéro de série
    Item No.: K800021-2, K800221-2, K802321-2 (Link) K801021-2, K801221-2, K802421-2 (AS/AS+) GV80011-2, GV82311-2 (Dako Omnis)  Catalog/Model No.: K8000 K8002 K8023 GV800  SM802 EnVision FLEX / HRP Lot 20019374 used in: Envision FLEX, High pH (link) Lot No.: 20019097, 20020777, 20021381 Envision FLEX+, Mouse, High pH (link) Lot No.: 20019103, 20019113, 20020772 EnVision FLEX Mini Kit, High pH (Link) Lot No.: 20021362  DM 842 EnVision FLEX / HRP (Dako Omnis) Lot 20019013 used in: EnVision FLEX, High pH (Dako Omnis) Lot No.: 20019102
  • Distribution
    Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the states of : TX, SD, CA, FL, MA, MD, WV, NC, OH, DE, MI, NJ, CO, HI, AR, NY, LA, GA, NV, RI, IL, OK, CT, MO, VA, and DC., and to the countries of : Canada, Brazil and Costa Rica.
  • Description du dispositif
    EnVision FLEX/HRP visualization reagent found in the following kits: || EnVision FLEX, High pH (Link) || EnVision FLEX+, Mouse, High pH (Link) || EnVision FLEX Mini Kit, High pH (Link) || EnVision FLEX, High pH (Dako Omnis) || Multi-component, sealed package. For in vitro diagnostic use.
  • Manufacturer
    Dako North America Inc.

Manufacturer

Dako North America Inc.
  • Adresse du fabricant
    Dako North America Inc., 6392 Via Real, Carpinteria CA 93013-2921
  • Société-mère du fabricant (2017)
    Agilent Technologies, Inc.
  • Source
    USFDA