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.
What this means for you
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 use.
- 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
Related recalls
Same manufacturer · Dako North America Inc.
See all →- ModerateDako PD-L1 IHC 22C3 pharmDx Recall for Storage Time Correction
FDA (Devices) · 2018-07-18
- ModerateDako HER2 CISH pharmDx Kit Recalled for Incorrect Probe Concentration
FDA (Devices) · 2016-07-06
- HighDako Omnis Software Module Recalled for Test Request Errors
FDA (Devices) · 2015-05-06
- HighDako Automated Slide Stainers Recalled for Potential Diagnostic Errors
FDA (Devices) · 2015-03-18
- ModerateDako Autostainer Link 48 Software Recall for Reagent Handling Issues
FDA (Devices) · 2014-10-01
Same hazard · diagnostic error
See all →- HighSiemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
FDA (Devices) · 2026-08-26
- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
- HighGEM Premier 5000 Blood Analyzer Recalled Over Bar Code Reader Patient ID Risk
FDA (Devices) · 2026-08-05
- HighPhilips IQon Spectral CT Recalled Due to Automatic Scan Trigger Failure
FDA (Devices) · 2026-08-05
- HighPhilips CT Scanners Recalled Due to Bolus Tracking Trigger Issue
FDA (Devices) · 2026-08-05