Recall Z-1927-2026 ยท PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Foundation Medicine, Inc.
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
| Date | Apr 22, 2026 (initiated Mar 20, 2026) |
| Status | Open, Classified |
| Reason | Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants |
| Root cause | Under Investigation by firm |
| Action | Foundation Medicine notified consignees via emailed letter on about 03/20/2026. Consignees were instructed to review, complete, sign and return the provided business reply form and review inventory and identify affected units, quarantine those units, and return to the FMI Boston Warehouse quarantine location via standard laboratory transfer practices. Consignees were also instructed to forward the notification to anyone within the facility that should be informed and if there is any impact that requires this notice to be forwarded to another facility, including facilities where units of inven |
| Quantity | 163 units |
| Distribution | US Nationwide distribution in the states of Massachusetts and North Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.