Sequencing Agent SEQ0067 — Class II medical device recall Z-1927-2026
Ongoing recall by Foundation Medicine, Inc., reported 2026-04-29, distributed nationwide. Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variant
| Recall number | Z-1927-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Foundation Medicine, Inc., Cambridge, MA, United States |
| Recall initiated | 2026-03-20 |
| Classified | 2026-04-22 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 163 units |
| Lot numbers | 24346, 24386, 24488 |
| Model numbers | SEQ0067 |
Product
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Reason for recall
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1927-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.