Recall Z-0563-2013— Dako Denmark A/S
Class II · Terminated
Class II FDA medical device recall by Dako Denmark A/S, initiated 2012-11-26, terminated 2013-05-14. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process..
- Recalling firm
- Dako Denmark A/S
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-26
- Terminated
- 2013-05-14
- Firm location
- Glostrup, Denmark
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.