FDA-Device2018-07-11Class II
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
Biocare Medical, LLC
Hazard
Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.
Sold states
CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany
Affected count
43 units
Manufactured in
60 Berry Dr, Pacheco, CA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2360-2018Don't want to check this manually?
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