intelliPATH Universal HRP Detection Kit, REF: IPK5011G80… recallZ-0315-2025 · Biocare Medical, LLC · initiated Sep 25, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biocare Medical, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On 9/25/24, recall notices were sent to customers and distributors who were asked to do the following: 1) Locate any affected kits in your possession and discontinue use. 2) Share this notification with all users within your facility and network to ensure all personnel who may use the kits are aware of this recall. 3) Discard any product remaining in your possession. 4) Complete and return the Response Form via email to [email protected] Distributors were asked to send the customer notice to their customers. Questions regarding this recall notification may be forwarded to [email protected] On 12/12/2024, recall notices were sent to customers containing additional affected lots.
Recall details
- Recall number
- Z-0315-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 25, 2024
- Posted by the FDA
- Nov 6, 2024
- Recalling firm
- Biocare Medical, LLC
- Quantity
- 976
- Product code
- PPM
- 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.
Product description
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
Code information (models, lots, serial numbers)
REF/UDI-DI/Kit Lot(DAB Lot): IPK5011G80/00847627009005/042324(012424A),060523(051823A), 082923(062923A), 011624(072723A), 042324(012424A), 080524(032624A); OPRI6056KT180/00847627024985/020624(111623A),032224(111623A-3); IPK5010G80/00847627008992/071923(051823A), 091923(081023A), 112823(101923A), 100424(011524A), 041624(022624A); OPRI6056KT180/00847627024985/071924(061824A); IPI4006KG10/00847627008985/080323(062923A), 102723(081023A)
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- intelliPATH Folate Receptor alpha IHC Assay Kit IPI4006KG10Biocare Medical LLC · Immunohistochemistry Reagents And Kits1 recall0 reports
- intelliPATH FLX™ DAB Chromogen Kit IPK5010G80Biocare Medical LLC · Immunohistochemistry Reagents And Kits1 recall0 reports
- intelliPATH™ Universal HRP Detection Kit IPK5011G80Biocare Medical LLC · Immunohistochemistry Reagents And Kits1 recall0 reports
- ONCORE Pro DAB Chromogen OPRI6056KT180Biocare Medical LLC · General Purpose Reagent1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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