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
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER