Biocare Vulcan Fast Red Chromogen Kit 2 Recall: Chromogen Stability Issue

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Recalling firmBiocare Medical, LLC60 Berry Dr · Pacheco, CA 94553-5601

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Biocare Medical is recalling Vulcan Fast Red Chromogen Kit 2 for potential chromogen failure in immunohistochemistry tests. This could affect lab results if the kit doesn't develop properly due to environmental factors.

Why it’s dangerous

The chromogen may fail to develop properly because of environmental factors affecting the raw material in the Vulcan Fast Red Buffer. This could lead to inaccurate lab results in immunohistochemistry tests.

Who’s affected

Lab technicians and pathologists using the Vulcan Fast Red Chromogen Kit 2 for immunohistochemistry procedures. Those with catalog numbers FR805-5L or FR805S are most at risk.

How to tell if you have this one

Check for catalog numbers FR805-5L or FR805S on the kit. Lot numbers 011818 and 022818 are also associated with this recall.

Brand
Biocare Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Verify the catalog number (FR805-5L or FR805S) and lot number (011818 or 022818) to confirm if the kit is affected.

✎ GovInfoNow

Questions people ask

Why is this kit being recalled?

The chromogen may fail to develop properly due to stability issues with the raw material in the Vulcan Fast Red Buffer.

What should I do if I have this kit?

Check the catalog number and lot number to see if it's affected; the recall does not require immediate action but verification is needed.

Is there a fix for this issue?

The recall record does not mention any remedy or fix for this issue.

Take action

Contact Biocare Medical

We’ve drafted a message you can send Biocare Medical to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2360-2018 — Biocare Medical Biocare Medical

Hello,

I own a Biocare Medical that is covered by recall Z-2360-2018 from Biocare Medical.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2360-2018 (April 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2360-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Biocare Medical, LLC recalls Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP)

Lower-risk recall