Events

Recall of COVERSTAINER SYSTEM - INSTRUMENT

According to Health Canada (via FOI), this recall involved a device in Canada 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
    76900
  • Event Risk Class
    II
  • Event Initiated Date
    2012-12-06
  • 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 expected life time of the coverstainer slide racks does not meet established performance requirements originating from variations into the manufacturing process. the result can be that slides are falling out of the rack during the staining process.

Device

COVERSTAINER SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: CS100 (Lot serial: ALL LOTS)
  • Product Description
    COVERSTAINER SLIDE RACK
  • Manufacturer
    DAKO DENMARK A/S

Manufacturer

DAKO DENMARK A/S