Events

Recall of Device Recall CoverStainer Slide Rack CS 10330

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dako Denmark A/S.

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
    63807
  • Event Risk Class
    Class 2
  • Event Number
    Z-0563-2013
  • Event Initiated Date
    2012-11-26
  • Event Date Posted
    2012-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114796
  • 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
    Slide stainer, automated - Product Code KPA
  • Reason
    The expected life time of the coverstainer slide racks (cs 10330) does not meet established performance requirements, originating from variations in the manufacturing process.
  • Action
    Dako sent a Voluntary Product Recall Notification dated November 13, 2012, to all affected customers. This voluntary recall notification was initiated because the expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process. The result can be that slides are falling out of the rack during the staining process. While this has been observed at only a few customer sites, the corrective action includes all CoverStainer installations. Customers were notified that Dako would correct the rack situation by using a new manufacturer and has imroved the rack design. Customers with questions were instructed to contact their local Dako representative. For questions regarding this recall call 805-566-3036.

Device

Device Recall CoverStainer Slide Rack CS 10330
  • Model / Serial
    The racks affected by this recall were distributed with the following CoverStainer instrument serial numbers in the U.S.:  CS 100-10031 CS 100-10033 CS 100-10035 CS 100-10054 CS 100-10080 CS 100-10081 CS 100-10082 CS 100-10083 CS 100-10093 CS 100-10094 CS 100-10106 CS 100-10107 CS 100-10110 CS 100-10113 CS 100-10117 CS 100-10123 CS 100-10124 CS 100-10125 CS 100-10133 CS 100-10135 CS 100-10148 CS 100-10149 CS 100-10150 CS 100-10152 CS 100-10159
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the following countries: Australia France Rep. of Korea Belgium Germany Russia Brazil Israel Saudi Arabia Canada Italy Spain Chile Japan Sweden China Mexico Taiwan Denmark Netherlands Turkey Ecuador Norway UK Finland Poland
  • Product Description
    CoverStainer Slide Rack || The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic slides, during transfer through the staining process. The rack can hold up to 10 slides at a time, and is necessary for optimal CoverStainer instrument performance.
  • Manufacturer
    Dako Denmark A/S

Manufacturer

Dako Denmark A/S
  • Manufacturer Address
    Dako Denmark A/S, Produktionsvej 42, Glostrup Denmark
  • Manufacturer Parent Company (2017)
    Agilent Technologies, Inc.
  • Source
    USFDA