FDA DeviceClass IINotable

FDA Recall: Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)

Date: 2026-04-29
Brand: Foundation Medicine, Inc.
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

163 units

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