CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory… — Class II medical device recall Z-0563-2013
Terminated recall by Dako Denmark A/S, reported 2012-12-26, distributed nationwide. The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requir
| Recall number | Z-0563-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dako Denmark A/S, Glostrup, Denmark |
| Recall initiated | 2012-11-26 |
| Classified | 2012-12-19 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2013-05-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, CL, CN, DE, DK, EC, ES, FI, FR, GB, IL, IT, JP, KR, MX, NL, NO, PL, RU, SA, SE, TR, TW |
| Serial numbers | 100-10031CS, 100-10033CS, 100-10035CS, 100-10054CS, 100-10080CS, 100-10081CS, 100-10082CS, 100-10083CS, 100-10093CS, 100-10094CS, 100-10106CS, 100-10107CS, 100-10110CS, 100-10113CS, 100-10117CS, 100-10123CS, 100-10124CS, 100-10125CS, 100-10133CS, 100-10135CS, 100-10148CS, 100-10149CS, 100-10150CS, 100-10152CS, 100-10159 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0563-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.