FDA Device recall Z-1927-2026
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
- FDA Device
- Class II
- ongoing
- Published 2026-04-29
On 2026-04-29 the FDA classified a Class II recall of Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) by Foundation Medicine, citing possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1927-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-20 |
| Published | 2026-04-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Foundation Medicine |
| Distribution | US |
Product
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Reason
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Identifiers
| code_info | Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1927-2026%22
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