← Back to all recalls
MEDICAL DEVICE RECALLMODERATE
FoundationOne CDx Sequencing Agent SEQ0067
Foundation Medicine is recalling Sequencing Agent SEQ0067 component of FoundationOne CDx due to possible false-positive BARD1 variants.
What to do
If you have received FoundationOne CDx test results using Sequencing Agent SEQ0067, contact Foundation Medicine immediately to discuss the potential impact on your results and whether retesting is recommended.
Why it was recalled
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
How to identify it
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Where it was sold
Distributed in US.
Official source
Other recent recalls from Foundation Medicine, Inc.
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification