Biocare Medical recalls intelliPATH Universal HRP Detection Kits with DAB buffer that may cause weak or no staining, leading to test failures. Affected kits include specific model numbers and lot codes.
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.
Biocare Medical is recalling certain intelliPATH Universal HRP Detection Kits that may cause weak or no staining during immunohistochemistry tests, requiring the test to be repeated. This could lead to inaccurate results and additional testing.
The DAB chromogen buffer in these kits may produce weak or no staining, which can cause test failures. This means the test results might be inaccurate, requiring the test to be repeated and potentially delaying diagnosis.
Pathologists and lab technicians using these kits for immunohistochemistry testing. Those most at risk are users who rely on the kits for accurate diagnostic results.
Check for the product name 'intelliPATH Universal HRP Detection Kit' with reference numbers IPK5011G80, IPK5010G80, or OPRI6056KT180. Look for specific lot codes listed in the recall notice.
Verify the reference number and lot code on the kit packaging to confirm if it is affected.
The DAB chromogen buffer in these kits may produce weak or no staining, leading to test failures that require repeating the test.
Check the reference number and lot code on the kit packaging to see if it is affected. If it is, contact Biocare Medical for further instructions.
No serious safety risks are associated with this recall. The issue is related to test accuracy, not physical harm.
We’ve drafted a message you can send Biocare Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0315-2025 — Biocare Medical Biocare Medical Hello, I own a Biocare Medical that is covered by recall Z-0315-2025 from Biocare Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
