Class 2 Device Recall CoverStainer Slide Rack CS 10330
|Date Initiated by Firm
||November 26, 2012
|Date Posting Updated
||December 19, 2012
||Terminated 3 on May 14, 2013
|Recall Event ID
||Slide stainer, automated - Product Code KPA
||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.
||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
| Dako Denmark A/S
|For Additional Information Contact
|The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process.
||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
||Worldwide Distribution - USA (nationwide) and the following countries:
Rep. of Korea
|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.