Reported Jul 11, 2018 · Terminated

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

Biocare Medical, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biocare Medical, LLC · 60 Berry Dr · Pacheco, CA · 94553-5601

Is this the product you have?

  • 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
Lot codes and dates
  • Lot numbers 011818 and 022818
Amount recalled
43 units

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 14, 2020 · Data as of Sep 19, 4:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.