# FDA recall Z-0315-2025

> **Biocare Medical, LLC** · Class II · device recall initiated 2024-09-25.

## Product

intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20;   ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60;  IP DAB Chromogen Kit 80 ml, REF: IPK5010G80,  containing DAB Buffer, Catalog Number: IPBF5009G20;  DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60  Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20

## Reason for recall

Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test to be repeated.

## Distribution

US Nationwide distribution in the states of MA, AZ, CT, NY, FL, NC, IN, IL, MO, CO, TX, CA, MI, PR, PA, MD, AL, OH, KY.

## Key facts

- **Recall number:** Z-0315-2025
- **Recalling firm:** Biocare Medical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-25
- **Report date:** 2024-11-13

- **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-0315-2025

## Citation

> AI Analytics. FDA recall Z-0315-2025. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-0315-2025. Source: US FDA. Licensed CC0.

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