Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision Recalled by Dako North America Inc. Due to There is a defect in one lot of...
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
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
Quantity: 300 units
Why Was This Recalled?
There is a defect in one lot of a buffer, non-specific background staining that has, in some instances, interfered with interpretation of the staining results.
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