FDA Device recall Z-0563-2013
CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument
- FDA Device
- Class II
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class II recall of CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument by Dako Denmark A S, citing the expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0563-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-26 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Dako Denmark A S |
| Distribution | US |
Product
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.
Reason
The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process.
Identifiers
| code_info | The racks affected by this recall were distributed with the following CoverStainer instrument serial numbers in the U.S…The racks affected by this recall were distributed with the following CoverStainer instrument serial numbers in the U.S.: CS 100-10031 CS 100-10033 CS 100-10035 CS 100-10054 CS 100-10080 CS 100-10081 CS 100-10082 CS 100-10083 CS 100-10093 CS 100-10094 CS 100-10106 CS 100-10107 CS 100-10110 CS 100-10113 CS 100-10117 CS 100-10123 CS 100-10124 CS 100-10125 CS 100-10133 CS 100-10135 CS 100-10148 CS 100-10149 CS 100-10150 CS 100-10152 CS 100-10159 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0563-2013%22
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