Dako North America Inc. recalls EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mou

Recalled November 11, 2015 · FDA recall Z-0220-2016 · Dako North America

Hazard

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. · FDA Class II

Units

300 units

Sold at

Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the states of : 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., and to the countries of : Canada, Brazil and Costa Rica.

Description

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.

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(s)

Dako North America Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →