# FDA recall Z-3198-2018

> **Biocare Medical, LLC** · Class II · device recall initiated 2018-03-15.

## 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

## Reason for recall

Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling of two components.

## Distribution

Worldwide Distribution - Unites States Nationwide in the states of NY AND FL    and the countries of: Morocco and Italy

## Key facts

- **Recall number:** Z-3198-2018
- **Recalling firm:** Biocare Medical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-15
- **Report date:** 2018-09-26
- **Termination date:** 2020-04-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pacheco, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3198-2018

## Citation

> AI Analytics. FDA recall Z-3198-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-3198-2018. Source: US FDA. Licensed CC0.

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