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 | Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components. |
| Product | URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, Package Type: Bottle, and b) CK20, Catalog #: PM062AA, Package Type: Bottle Product Usage: URO-3 Triple Stain (CD44 + p53) with CK20 is a cocktail of mouse monoclonal and rabbit monoclonal antibodies that is intended for laboratory use in the qualitative identification of CD44, p53 and CK20 proteins by immunohistochemistry (IHC) in formalin-fixed paraffin-embedded (FFPE) human tissues, primarily for bladder cancer characterization. The clinical… |
| Quantity | 11 |
| Distribution | Worldwide Distribution - Unites States Nationwide in the states of NY AND FL and the countries of: Morocco and Italy |
| Initiated | 2018-03-15 |
| Classified | 2018-09-19 |
| Terminated | 2020-04-22 |
| Recall number | Z-3198-2018 |
| 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-3198-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80407/
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