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U.S. Department of Health and Human Services

Class 2 Device Recall CoverStainer Slide Rack CS 10330

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  Class 2 Device Recall CoverStainer Slide Rack CS 10330 see related information
Date Initiated by Firm November 26, 2012
Date Posted December 19, 2012
Recall Status1 Terminated 3 on May 14, 2013
Recall Number Z-0563-2013
Recall Event ID 63807
Product Classification Slide stainer, automated - Product Code KPA
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.
Code Information 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
Recalling Firm/
Manufacturer		 Dako Denmark A/S
Produktionsvej 42
Glostrup Denmark
For Additional Information Contact Goran Mattson
452199589
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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