Class II — Biocare Medical, LLC
| Recalling firm | BIOCARE HOLDINGS, LLC |
|---|---|
| Registered facility | BIOCARE MEDICAL, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer. |
| 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 |
| Quantity | 43 units |
| Distribution | CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany |
| Initiated | 2018-04-24 |
| Classified | 2018-07-05 |
| Terminated | 2020-07-14 |
| Recall number | Z-2360-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Biocare Medical, LLC (Z-2360-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80322/
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