Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Autostainer Link 48 (AS480) Recalled by Dako North America Inc. Due to A false negative result affecting the diagnosis may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Dako North America Inc. directly.
Affected Products
Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.
Quantity: 409
Why Was This Recalled?
A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock component may, in some circumstances, cause leakage of excess buffer onto slide location 34 on the AS480, or slide locations 35 and 36 on the AS100, S3400, and S3800. Affected dates are from 12/2013-08/2014.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Dako North America Inc.
Dako North America Inc. has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report