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Lower risk Medical device recall · FDA · Published September 25, 2024

Biocare Medical intelliPATH HRP Detection Kit May Cause Test Failures

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0315-2025Medical deviceBiocare Medical ›
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Contact the company

Recalling firmBiocare Medical, LLC60 Berry Dr · Pacheco, CA 94553-5601
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/53863-biocare-medical-intellipath-hrp-detection-kit-may-cause-test-failures.

Source Summary by GovInfoNow · govinfonow.com/recall/53863-biocare-medical-intellipath-hrp-detection-kit-may-cause-test-failures · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0315-2025

Cite this page

“Biocare Medical intelliPATH HRP Detection Kit May Cause Test Failures.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/53863-biocare-medical-intellipath-hrp-detection-kit-may-cause-test-failures. Based on FDA recall #Z-0315-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0315-2025%22&limit=1).

The FDA announced on September 25, 2024, that Biocare Medical, LLC is recalling intelliPATH Universal HRP Detection Kits and related products containing DAB Buffer. The agency issued recall number Z-0315-2025 for the voluntary Class II action affecting 976 units distributed nationwide.

How to tell if you have it

  • Brand: Biocare Medical
  • Product: intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, Catalog Number: OPRI6055T60
  • Product: IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5009G20
  • Product: DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60
  • Product: Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20
  • Lot codes: 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)

The hazard

According to the FDA, kits containing the DAB chromogen buffer may produce weak to no staining in manual or automated Immunohistochemistry (IHC) staining protocols. This defect may lead to test failure requiring the test to be repeated.

Context

GovInfoNow's records show Biocare Medical, LLC has 4 other recalls on record since 2018-03-15. Other recent recalls include a 2021-02-25 software issue with the Biocare IntelliPath FLX Staining Instrument and a 2019-10-10 invalid test results risk for the Biocare Medical 4plus Streptavidin HRP Label. Other recent recalls of similar products include Siemens Atellica CH A1c_E Hemoglobin Test May Give Low Results (2026-02-23) and TECHNO-PATH Multichem ID-B Serum Recall: Risk of False Negative HIV/Hepatitis Tests (2025-10-17).

How to tell if you have this one

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.

  • Brand
    Biocare Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Details

    Verify the reference number and lot code on the kit packaging to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 18 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA 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 read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kentucky, Maryland, Massachusetts, Michigan, Missouri, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, Texas.

Recall timeline

FDA published this recall 49 days after the firm started it.

1. Firm started the recall: Sep 25, 202412. FDA classified it Class II: Nov 6, 202423. Published in FDA’s Enforcement Report: Nov 13, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are there any safety risks from using this kit?

No serious safety risks are associated with this recall. The issue is related to test accuracy, not physical harm.

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Where this comes from

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.

  • Official source: FDA Recall #Z-0315-2025 (September 25, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0315-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA