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

Recall date

April 24, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2360-2018

FDA classification

Class II

Brand / firm

Biocare Medical, LLC

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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