Events

Recall of Device Recall Eridan Automated slide stainer.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dako Colorado, 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
    36597
  • Event Risk Class
    Class 2
  • Event Number
    Z-0199-2007
  • Event Initiated Date
    2006-10-02
  • Event Date Posted
    2006-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48967
  • 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
    Automated slide stainer - Product Code KPA
  • Reason
    Automated slide staining device may not stain speciman slides correctly, and therefore slides cannot be used for patient diagnosis.
  • Action
    Consignees were notified by phone on 10/02/2006 and later by letter on 10/20/2006. They were given the option of using the stainer as 'Research Use Only' or having the stainer returned to Dako.

Device

Device Recall Eridan Automated slide stainer.
  • Model / Serial
    Serial numbers: ER103, ER105, ER106, ER107, ER108, ER110, ER111, ER113, ER115, ER117, ER118.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution --- USA including states of CA, IN, NC, WA and countries of Denmark, France, Germany, and Spain.
  • Product Description
    Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, Dako Colorado, Inc. || (Catalog No. (ER 00130,00331,00230,00431)
  • Manufacturer
    Dako Colorado, Inc.

Manufacturer

Dako Colorado, Inc.
  • Manufacturer Address
    Dako Colorado, Inc., 4850 Innovation Dr, Fort Collins CO 80525-5576
  • Source
    USFDA