Foundation Medicine, Inc. recalls Sequencing Agent SEQ0067, component of FoundationOne CDx (F1
See all recalls from Foundation Medicine, Inc. →Recalled Product
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Hazard / Issue
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488.
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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