Biocare Vulcan Fast Red Chromogen Kit 2 Recall: Chromogen Stability Issue
Biocare Medical recalls Vulcan Fast Red Chromogen Kit 2 (FR805-5L, FR805S) due to stability issues with raw materials causing chromogen failure in IHC procedures.
Lower-risk recall
Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.
Contact the company
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. Read more at govinfonow.com/recall/71349-biocare-vulcan-fast-red-chromogen-kit-2-recall-chromogen-stability.
Source Summary by GovInfoNow · govinfonow.com/recall/71349-biocare-vulcan-fast-red-chromogen-kit-2-recall-chromogen-stability · Updated August 21, 2026 · FDA enforcement record: FDA #Z-2360-2018
Cite this page
“Biocare Vulcan Fast Red Chromogen Kit 2 Recall: Chromogen Stability Issue.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71349-biocare-vulcan-fast-red-chromogen-kit-2-recall-chromogen-stability. Based on FDA recall #Z-2360-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2360-2018%22&limit=1).
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
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.
Where it went and when
Where it was distributed
Distributed in 12 states, and outside the U.S.
FDA distribution: “CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Oregon, Rhode Island, Texas, Vermont.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
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.
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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.