Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | March 20, 2026 |
| Reported | April 29, 2026 |
| Recalling firm | Foundation Medicine, Inc. |
| Country / region | United States MA |
Hazard
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Affected products
- Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Related recalls
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755PMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vaSwan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros;