# FDA recall Z-2360-2018

> **Biocare Medical, LLC** · Class II · device recall initiated 2018-04-24.

## 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.

## Distribution

CA, VT, KY, LA, OR, RI, GA, IL, MA, TX, KS, FL, Japan, and Germany

## Key facts

- **Recall number:** Z-2360-2018
- **Recalling firm:** Biocare Medical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-24
- **Report date:** 2018-07-11
- **Termination date:** 2020-07-14

- **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-2360-2018

## Citation

> AI Analytics. FDA recall Z-2360-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2360-2018. Source: US FDA. Licensed CC0.

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