Vulcan Fast Red Chromogen Kit 2 — Class II medical device recall Z-2360-2018
Terminated recall by Biocare Medical, LLC, reported 2018-07-11, distributed in CA, FL, GA, IL, KS, KY, LA, MA…. Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in th
| Recall number | Z-2360-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biocare Medical, LLC, Pacheco, CA, United States |
| Recall initiated | 2018-04-24 |
| Classified | 2018-07-05 |
| Reported by FDA | 2018-07-11 |
| Terminated | 2020-07-14 |
| Distributed | CA, FL, GA, IL, KS, KY, LA, MA, OR, RI, TX, VT |
| Countries outside the US | DE, JP |
| Quantity | 43 units |
| Reason classes | specification failure |
| Lot numbers | 011818, 022818 |
| Model numbers | FR805-5L, FR805S |
Product
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
Reason for recall
Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2360-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.