Recall Z-0649-2019 ยท PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Foundation Medicine, Inc.
FoundationOne CDx Test Results
| Date | Dec 20, 2018 (initiated Oct 31, 2018) |
| Status | Terminated |
| Reason | An incorrect test result for a single analyte may have been reported for up to 800 physician reports |
| Root cause | Other |
| Action | On October 31, 2108, an outreach program was implemented by Foundation Medicine's Medical Affairs team to advise ordering physicians who received reports of possibility that the relevant reports could contain an incorrect test result. |
| Quantity | 800 reports |
| Distribution | US nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.