Dakocytomation California Inc EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4000 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a component in various finished assay kits and as a standalone product. Model Number K4000
Brand
Dakocytomation California Inc
Lot Codes / Batch Numbers
K4000: Lots 065021 & 085031
Products Sold
K4000: Lots 065021 & 085031
Dakocytomation California Inc is recalling EnVision+, an ImmunoHistoChemistry reagent. This in-vitro diagnostic (reagent) is marketed both as a due to This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
Recommended Action
Per FDA guidance
Notification letter dated October 14, 2005 was sent by certified mail to cosignees instructing dosposal of product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026