Reported Nov 13, 2024 · Ongoing
intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE…
Biocare Medical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biocare Medical, LLC · 60 Berry Dr · Pacheco, CA · 94553-5601
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
IPBF5009G20 | intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer |
OPRI6055T60 | ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer |
IPBF5009G20 | IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer |
IPBF5009G20 | DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60 Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer |
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 00847627009005IPK5011G80/00847627009005/042324(012424A),060523(051823A), 082923(062923A), 011624(072723A), 042324(012424A), 080524(032624A) 2 00847627024985OPRI6056KT180/00847627024985/020624(111623A),032224(111623A-3) 3 00847627008992IPK5010G80/00847627008992/071923(051823A), 091923(081023A), 112823(101923A), 100424(011524A), 041624(022624A) 4 00847627024985OPRI6056KT180/00847627024985/071924(061824A) 5 00847627008985IPI4006KG10/00847627008985/080323(062923A), 102723(081023A) - Amount recalled
- 976
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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