fda_recall · device_recall · high

Foundation Medicine, Inc. — Class II recall: Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

Event date
2026-04-29 00:00:00Z
Observed
2026-07-09 22:53:01Z
Source ID
Z-1927-2026
Payload hash
f9159f321ffef7d8b44e38f6

Summary

Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants Status: Ongoing.

Informational only. Not legal, financial, or medical advice.