FDAApril 24, 2018device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.
What to do
FDA enforcement status: Terminated
Brands named
biocare medicalbiocare
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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