Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported November 13, 2024
intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5009G20; DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60 Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20
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 …
Biocare Medical, LLC recalled intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog … - a moderate-severity action.
intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog … was recalled by Biocare Medical, LLC in November 13, 2024. Reason: Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry…. Check the official notice for the remedy. Verify recall #Z-0315-2025 with the FDA Devices before acting.
The recall
Biocare Medical, LLC issued this moderate-severity FDA Devices recall-Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry….
- Moderate
- severity level
- 976 units
- affected scope
- Class II
- classification
- November 13, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0315-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0315-2025) was formally reported on November 13, 2024, with the manufacturer initiating the action on September 25, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Biocare Medical, LLC is listed as the recalling firm, operating out of Pacheco, CA. Federal records list the affected scope as 976.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
976
Related Recalls
6
3 from same agency
Product description
intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5009G20; DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60 Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0315-2025 |
| Date reported | November 13, 2024 |
| Date initiated | September 25, 2024 |
| Recalling firm | Biocare Medical, LLC |
| Firm location | Pacheco, CA |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0315-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5009G20; DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60 Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20. Recalled by Biocare Medical, LLC. Units affected: 976.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2024. Severity: Moderate. Recall number: Z-0315-2025.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0315-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 13, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.