Foundation Medicine, Inc. is recalling 163 units of Sequencing Agent SEQ0067, which is a component used in the FoundationOne CDx (F1CDx) cancer genomic test. The recall was initiated because a technical issue may cause an increase in 'phasing,' which can lead to false-positive test results for specific genetic variants (BARD1 splice site indels). While no injuries or incorrect treatments have been reported to date, these sequencing agents were distributed to laboratories in Massachusetts and North Carolina in early 2026.
A false-positive result means the test might incorrectly indicate a specific genetic mutation is present when it is not. This could lead a healthcare provider to recommend a targeted therapy or clinical trial that is not actually appropriate for the patient's specific cancer profile.
Component of the FoundationOne CDx (F1CDx) assay.
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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