intelliPATH Universal HRP Detection Kit — Class II medical device recall Z-0315-2025
Ongoing recall by Biocare Medical, LLC, reported 2024-11-13, distributed nationwide. Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry
| Recall number | Z-0315-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biocare Medical, LLC, Pacheco, CA, United States |
| Recall initiated | 2024-09-25 |
| Classified | 2024-11-06 |
| Reported by FDA | 2024-11-13 |
| Distributed | Nationwide (US) |
| Quantity | 976 |
| UPC / GTIN / UDI-DI | 00847627008985, 00847627008992, 00847627009005, 00847627024985 |
| Model numbers | IPBF5009G20, IPI4006KG10, IPK5010G80, IPK5011G80, OPRI6055T60, OPRI6056KT180 |
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.
Machine access
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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.