FDA-Device2012-12-26Class II
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.
Dako Denmark A/S
Hazard
The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process.
Sold states
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
Affected count
25 Units US (50-100 racks per unit) 106 total
Manufactured in
Produktionsvej 42, Glostrup, Denmark
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0563-2013Don't want to check this manually?
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