Biocare Medical, LLC recalls Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) dete

Recalled July 11, 2018 · FDA recall Z-2360-2018 · Biocare Medical

Hazard

Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer. · FDA Class II

Units

43 units

Sold at

CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany

Description

Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.

Product

Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L and FR805S

Manufacturer(s)

Biocare Medical, LLC

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