Dako Denmark A/S
Dako Denmark A/S has 3 FDA enforcement events on this register (3 product records) between 2012 and 2019: 3 device; the busiest year was 2012 with 1.
0% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in N/A.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 5 Nov 2019 | Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800. | Device | Class II | 1 | Terminated |
| 6 Jul 2016 | EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments. | Device | Class II | 1 | Terminated |
| 26 Nov 2012 | 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. | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Dako Denmark A/S had?
3 enforcement events (3 product records) on this register, 2012–2019: 3 device.
Are any Dako Denmark A/S recalls ongoing?
0 events are listed as ongoing in the current openFDA export.
What class are Dako Denmark A/S recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.