Z-0563-2013Class II

CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The...

Name: Z-0563-2013 CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The...
Creator: Dako Denmark A/S
Published: 2012-11-26
License: https://open.fda.gov/license/

Agilent Technologies Denmark ApS / initiated 2012-11-26 / Terminated / root cause: design

FDA source

Dako Denmark A/S began a recall of CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic slides, during transfer... on 2012-11-26. FDA classified it as Class II and gives the reason 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0563-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-26
Posted: 2012-12-19
Terminated: 2013-05-14
Recalling firm: Agilent Technologies Denmark ApS
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.
Product code: KPA Slide Stainer, Automated
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.
Root cause tag: design
FDA root cause: Device Design
Action: Dako sent a Voluntary Product Recall Notification dated November 13, 2012, to all affected customers. This voluntary recall notification was initiated because the expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process. The result can be that slides are falling out of the rack during the staining process. While this has been observed at only a few customer sites, the corrective action includes all CoverStainer installations. Customers were notified that Dako would correct the rack situation by using a new manufacturer and has imroved the rack design. Customers with questions were instructed to contact their local Dako representative. For questions regarding this recall call 805-566-3036.
Quantity in commerce: 25 Units US (50-100 racks per unit) 106 total
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 Mexico Taiwan Denmark Netherlands Turkey Ecuador Norway UK Finland Poland
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0563-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0563-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-19

Product code KPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)