URO-3 Triple Stain — Class II medical device recall Z-3198-2018
Terminated recall by Biocare Medical, LLC, reported 2018-09-26, distributed nationwide. Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two compone
| Recall number | Z-3198-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biocare Medical, LLC, Pacheco, CA, United States |
| Recall initiated | 2018-03-15 |
| Classified | 2018-09-19 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2020-04-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | IT, MA |
| Quantity | 11 |
| Reason classes | labeling |
| Lot numbers | 060117, 060617, 2019/05 |
| Model numbers | PM062AA, PM370TSAA, PM373DSAA |
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 interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient s clinical history and other diagnostic tests by a qualified pathologist. The URO-3 Triple Stain is an adjunct immunohistochemistry test to assist a qualified pathologist in differentiating urothelial reactive atypia from CIS (carcinoma in situ) in suspected bladder lesions. The URO-3 staining pattern will be used as supporting data along with morphological and patient history context for the qualified pathologist to render a diagnosis.
Reason for recall
Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.
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-3198-2018. 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.