Biocare Medical has recalled approximately 976 units of various kits containing DAB chromogen buffer, including the intelliPATH Universal HRP Detection Kit and ONCORE Pro DAB Chromogen. These kits, used for manual or automated tissue staining in diagnostic laboratories, may produce weak or no staining on test slides. This defect can lead to test failures that require medical professionals to repeat the diagnostic tests. Consumers should identify affected lot numbers immediately and contact the manufacturer for further instructions.
The buffer may fail to produce the necessary chemical reaction for tissue staining, which can result in unreadable test results or false-negative interpretations. This requires the diagnostic procedure to be repeated, potentially delaying critical medical results for patients.
Contact the manufacturer for guidance on defective kits.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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