Dako CoverStainer Slide Rack Recalled for Performance Defects
Dako Denmark A/S is recalling CoverStainer Slide Racks because their expected lifetime does not meet performance requirements due to manufacturing variations.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a performance defect (lifetime not meeting requirements) rather than a direct safety risk like fire or toxic exposure, fitting the 'Moderate' criteria for low-risk issues or voluntary precautionary measures without reported harm.
Plain-English summary
Dako Denmark A/S is recalling the CoverStainer Slide Rack, an accessory used to hold microscopic slides during the staining process. The recall is due to manufacturing process variations that cause the racks' expected lifetime to fail to meet established performance requirements.
The affected racks were distributed worldwide, including nationwide in the United States and in numerous other countries. In the U.S., the racks were distributed with specific CoverStainer instrument serial numbers, which are listed in the official recall documentation. The total quantity affected is 106 racks.
Users of these racks should stop using them and contact Dako Denmark A/S for instructions on replacement or return. The racks are necessary for optimal instrument performance, and using defective units may impact the staining process.
The recalled product
- 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…
- Manufacturer
- Dako Denmark A/S
- Hazard
Distribution
Distributed nationwide across the United States.
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