Dako EnVision FLEX Visualization Reagent Recalled for Staining Defect
Dako North America Inc. is recalling specific lots of EnVision FLEX visualization reagent kits due to a buffer defect causing non-specific background staining that interferes with result interpretation.
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 hazard is a diagnostic accuracy issue (background staining) rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Dako North America Inc. is recalling 300 units of EnVision FLEX/HRP visualization reagent kits, including EnVision FLEX, High pH (Link), EnVision FLEX+, Mouse, High pH (Link), EnVision FLEX Mini Kit, High pH (Link), and EnVision FLEX, High pH (Dako Omnis). The recall involves specific lots identified by item numbers K800021-2, K800221-2, K802321-2, K801021-2, K801221-2, K802421-2, GV80011-2, and GV82311-2, as well as specific lot numbers such as 20019097, 20020777, and 20019102.
The recall is due to a defect in one lot of a buffer that results in non-specific background staining. This defect has, in some instances, interfered with the interpretation of the staining results. The affected products are multi-component, sealed packages intended for in vitro diagnostic use.
The products were distributed nationwide in the United States, including Puerto Rico and specific states such as TX, SD, CA, FL, MA, MD, WV, NC, OH, DE, MI, NJ, CO, HI, AR, NY, LA, GA, NV, RI, IL, OK, CT, MO, VA, and DC. Distribution also extended to Canada, Brazil, and Costa Rica. Users should check their inventory for the specific lot numbers listed in the recall notice and stop using the affected products.
The recalled product
- Product
- 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…
- Manufacturer
- Dako North America Inc.
- Hazard
- Affected units
- 300
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Item No.: K800021-2
- K800221-2
- K802321-2 (Link) K801021-2
- K801221-2
- K802421-2 (AS/AS+) GV80011-2
- High pH (link) Lot No.: 20019097
- 20020777
- 20021381 Envision FLEX+
- Mouse
- High pH (link) Lot No.: 20019103
- 20019113
- 20020772 EnVision FLEX Mini Kit
- High pH (Dako Omnis) Lot No.: 20019102
Distribution
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