Skip to main content
Recall Canary
FoundationOne CDx Sequencing Agent SEQ0067
← 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.

Recalled
Listed
Updated
Recall No.
Z-1927-2026
Agency
FDA
Firm
Foundation Medicine, Inc.
Recall ID
98625
Status
ONGOING

Recall at a glance

Quantity recalled
163 units

Why it was recalled

Foundation Medicine is recalling Sequencing Agent SEQ0067, a component of the FoundationOne CDx (F1CDx) genomic testing system, due to a possible increase in phasing that could result in false-positive BARD1 splice site indel artifact variants in test results.

Is mine affected?

This recall covers the product below. If you have it, yours is affected.

Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other recent recalls from Foundation Medicine, Inc.

All recalls from Foundation Medicine, Inc.

← Back to all recalls

Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification