Recall Z-1891-2025 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 Feb 15, 2023) |
| Status | Open, Classified |
| Reason | An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report. |
| Root cause | Software design |
| Action | On February 15, 2023, the physician was alerted of the amended report within the physician's portal. Physician was informed original report included an incorrect negative CDx claim on the claims page; the CDx variant information was displayed correctly in the tumor profiling section of the FDA-approved test report. It is requested that any impact to patient care be forwarded to Foundation Medicine. |
| Quantity | 1 unit |
| Distribution | US Nationwide distribution in the state of WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.