medical Class II Updated 2018-07-11

Biocare Medical, LLC recalls Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemi

Recalled 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

Hazard / Issue

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

Issued by

FDA

Affected States: CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL
Lot/Code Info: Lot numbers 011818 and 022818
View official government recall

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