Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Vulcan Fast Red Chromogen Kit 2 Recalled by Biocare Medical, LLC Due to Chromogen failed to develop due to a stability...

Date: April 24, 2018
Company: Biocare Medical, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Biocare Medical, LLC directly.

Affected 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

Quantity: 43 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 12 states: CA, FL, GA, IL, KS, KY, LA, MA, OR, RI, TX, VT

Affected (12 states)Not affected

About Biocare Medical, LLC

Biocare Medical, LLC has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report