Recall Z-0563-2013
Dako Denmark A/S · initiated November 26, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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
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: Device Design
Action taken
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.
Details
- Recall number
- Z-0563-2013
- Initiated
- November 26, 2012
- Posted by FDA
- December 19, 2012
- Terminated
- May 14, 2013
- Product code
- KPA – Slide Stainer, Automated
- Quantity
- 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
- Recalling firm
- Dako Denmark A/S, Glostrup