Events

Recall of EnVision Model Number K4000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dakocytomation California Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    33957
  • Event Risk Class
    Class 2
  • Event Number
    Z-0310-06
  • Event Initiated Date
    2005-10-14
  • Event Date Posted
    2005-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42798
  • Notes / Alerts
    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.
  • Extra notes in the data
    Immunohistochemistry Reagents And Kits - Product Code NJT
  • Reason
    This recall has been initiated due to a formulation error in the envision+ visualization reagent.
  • Action
    Notification letter dated October 14, 2005 was sent by certified mail to cosignees instructing dosposal of product.

Device

EnVision Model Number K4000
  • Model / Serial
    K4000: Lots 065021 & 085031
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide to: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. Worldwide to: Argentina, Bermuda, Brazil, Canada, Costa Rica, Denmark, Japan, Mexico, New Zealand, and Uruguay.
  • Product Description
    EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4000
  • Manufacturer
    Dakocytomation California Inc

Manufacturer

Dakocytomation California Inc
  • Manufacturer Address
    Dakocytomation California Inc, 6392 Via Real, Carpinteria CA 93013-2921
  • Source
    USFDA