FDA DevicesClass II
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Published: April 29, 2026Recall ID: Z-1927-2026Category: devicesCountry: US
Reason for Recall / Hazard
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Product Description & Identification
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Additional Source Details
| Field | Value |
|---|---|
| City | Cambridge |
| State | MA |
| Event id | 98625 |
| Address 1 | 150 2nd St |
| Address 2 | N/A |
| Code info | Model Number: SEQ0067. Lot Numbers: 24346, 24386, 24488. |
| Postal code | 02141-2115 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 163 units |
| Reason for recall | Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260320 |
| Initial firm notification | |
| Center classification date | 20260422 |
Overview
- Recalling FirmFoundation Medicine, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of Massachusetts and North Carolina.