Foundation Medicine Sequencing Agent SEQ0067 Recall: False-Positive BARD1 Artifacts
Foundation Medicine recalls Sequencing Agent SEQ0067 (lot 24346, 24386, 24488) due to possible false-positive BARD1 variants in cancer testing. Affected users should contact for details.
Lower-risk recall
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Contact the company
What happened, in plain English
Foundation Medicine is recalling Sequencing Agent SEQ0067, used in cancer genetic testing. This component may cause false-positive results for BARD1 gene variants, which could lead to incorrect cancer diagnoses. Read more at govinfonow.com/recall/49654-foundation-medicine-sequencing-agent-seq0067-recall-false-positive-bard1-artifacts.
Source Summary by GovInfoNow · govinfonow.com/recall/49654-foundation-medicine-sequencing-agent-seq0067-recall-false-positive-bard1-artifacts · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1927-2026
Cite this page
“Foundation Medicine Sequencing Agent SEQ0067 Recall: False-Positive BARD1 Artifacts.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49654-foundation-medicine-sequencing-agent-seq0067-recall-false-positive-bard1-artifacts. Based on FDA recall #Z-1927-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1927-2026%22&limit=1).
Why it’s dangerous
The Sequencing Agent may cause false-positive BARD1 splice site indel artifact variants during cancer genetic testing. This could lead to incorrect cancer diagnoses if the false results are interpreted as real mutations.
Who’s affected
Users of FoundationOne CDx (F1CDx) cancer testing kits who purchased Sequencing Agent SEQ0067 with lot numbers 24346, 24386, or 24488 are affected. Patients and healthcare providers using these kits are at risk of inaccurate test results.
How to tell if you have this one
Check if you have Sequencing Agent SEQ0067 with lot numbers 24346, 24386, or 24488. This component is part of FoundationOne CDx (F1CDx) cancer testing kits.
- Brand
Foundation Medicine- Category
Medical device
What to do — step by step
Contact Manufacturer
Reach out to Foundation Medicine directly for specific instructions on handling the recalled item.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “US Nationwide distribution in the states of Massachusetts and North Carolina.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Massachusetts, North Carolina.
Recall timeline
FDA published this recall 40 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-1927-2026 (March 20, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1927-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.