Recall Z-1890-2025 ยท PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Foundation Medicine, Inc.
FoundationOne Companion Diagnostic (F1CDx)
| Date | May 30, 2025 (initiated Jun 18, 2024) |
| Status | Open, Classified |
| Reason | Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the device variant information was displayed correctly in the tumor profiling section of both FDA-approved test reports. |
| Root cause | Software design |
| Action | On June 18, 2024, amended reports were sent to customers. It was to alert customers to an amended report that was recently released on 6/18/24. The new report replaces the report of 2/11/24. Additional contact was made on June 20, 2024 to communicate the error and provide the updated report to the customer. |
| Quantity | 2 units |
| Distribution | US Nationwide distribution in the state of MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.