FDA Medical devices recall ·
intelliPATH Universal HRP Detection Kit recall
- Recall number
- Z-0315-2025
- Date
- (initiated September 25, 2024)
- Company / brand
- Biocare Medical, LLC
60 Berry Dr, Pacheco, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 976
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot 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)
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.
States: Alabama Arizona California Colorado Connecticut Florida Illinois Indiana Kentucky Massachusetts Maryland Michigan Missouri North Carolina New York Ohio Pennsylvania Puerto Rico Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0315-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.