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Medical Device

Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

Recall date: 2026-04-29 · Source: FDA_DEVICE
Brand / Firm
Foundation Medicine, Inc.
Product
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Reason for recall
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Units affected
163 units
Description
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
View official recall notice →