Food, drugs, devices › Dako Denmark A/S
Device recall: CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to ho
FDA enforcement event 63807 is a device recall by Dako Denmark A/S of Glostrup, initiated 26 Nov 2012 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 14 May 2013. Initiation: voluntary: firm initiated. Dako Denmark A/S has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Dako Denmark A/S, Glostrup, Denmark.
Reason for recall
"The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process."
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…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0563-2013 | 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. | 25 Units US (50-100 racks per unit) 106 total | Class II | Terminated | 26 Dec 2012 |
Context
Other enforcement events for Dako Denmark A/S
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 5 Nov 2019 | Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostain | Device | Class II | 1 |
| 6 Jul 2016 | EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with | Device | Class II | 1 |
All 3 events for Dako Denmark A/S
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 May 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.