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

Products covered by this recall
Model / numberProduct as published
IPBF5009G20intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer
OPRI6055T60ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer
IPBF5009G20IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer
IPBF5009G20DAB 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
#BarcodesProduct as published
100847627009005IPK5011G80/00847627009005/042324(012424A),060523(051823A), 082923(062923A), 011624(072723A), 042324(012424A), 080524(032624A)
200847627024985OPRI6056KT180/00847627024985/020624(111623A),032224(111623A-3)
300847627008992IPK5010G80/00847627008992/071923(051823A), 091923(081023A), 112823(101923A), 100424(011524A), 041624(022624A)
400847627024985OPRI6056KT180/00847627024985/071924(061824A)
500847627008985IPI4006KG10/00847627008985/080323(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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new produce recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.