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
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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
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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 |
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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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