intelliPATH Universal HRP Detection Kit recall
intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF…
Why was intelliPATH Universal HRP Detection Kit 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)
- Product
- intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF…
- Recalling firm
- Biocare Medical, LLC
- Quantity
- 976
- 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.
- Recall date
- November 13, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)