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.
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
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.
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.
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.
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.
Reach out to Foundation Medicine directly for specific instructions on handling the recalled item.
Foundation Medicine recalls Sequencing Agent SEQ0067 (lot numbers 24346, 24386, 24488) due to possible false-positive BARD1 variants in cancer testing.
Check the lot number on your Sequencing Agent SEQ0067; affected lots are 24346, 24386, and 24488.
Contact Foundation Medicine directly for specific instructions on handling the recalled item.
We’ve drafted a message you can send Foundation Medicine to request your refund or repair — edit it as you like.
Subject: Recall Z-1927-2026 — Foundation Medicine Foundation Medicine Hello, I own a Foundation Medicine that is covered by recall Z-1927-2026 from Foundation Medicine. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
