Events

Recall of DAKO SEYMOUR SMALL FLAP SLIDE LABEL KIT (ACCESSORY TO DEVICES ARTISAN LINK PRO AND AUTOSTAINER LINK PRO)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AGILENT TECHNOLOGIES CANADA 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
    63278
  • Event Risk Class
    III
  • Event Initiated Date
    2015-12-14
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    The kits were mislabeled for multiple lots. the product specifications for kit requires the description on the label to state "dako seymour small flap slide label kit". instead the label reads" dako seymour large flap slide label kit".

Device

DAKO SEYMOUR SMALL FLAP SLIDE LABEL KIT (ACCESSORY TO DEVICES ARTISAN LINK PRO AND AUTOSTAINER LI...
  • Model / Serial
    Model Catalog: DL213 (Lot serial: >10 Contact manufacturer)
  • Product Description
    DAKO SEYMOUR SMAL FLAP SLIDE LABEL KIT
  • Manufacturer
    AGILENT TECHNOLOGIES CANADA INC.

Manufacturer

AGILENT TECHNOLOGIES CANADA INC.