Events

Recall of ARTISAN LINK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DAKO NORTH AMERICA 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
    80209
  • Event Risk Class
    II
  • Event Initiated Date
    2017-12-20
  • 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
    A fume test has been conducted and set-up to measure the emission of formaldehyde from the artisan instrument. results for the fume test showed that the emission of formaldehyde exceeds the threshold limits set by the following provinces in canada: manitoba newfoundland & labrador nova scotia prince edward island.

Device

ARTISAN LINK
  • Model / Serial
    Model Catalog: AR210 (Lot serial: ADL611070); Model Catalog: AR210 (Lot serial: ADL511070); Model Catalog: AR210 (Lot serial: ADL610220); Model Catalog: AR210 (Lot serial: ADL711120); Model Catalog: AR310 (Lot serial: ALPB12140); Model Catalog: AR100 (Lot serial: n/a)
  • Product Description
    ARTISAN LINK;ARTISAN LINK PRO;ARTISAN AUTOMATED SLIDE STAINER
  • Manufacturer
    DAKO NORTH AMERICA INC.

Manufacturer

DAKO NORTH AMERICA INC.