Recall Z-0535-2020 ยท PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Foundation Medicine, Inc.
FoundationOne CDx test report
| Date | Aug 8, 2019 |
| Status | Terminated |
| Reason | Identified potential false positive MSI-H on the test reports provided to the physicians. |
| Root cause | Under Investigation by firm |
| Action | Firm informed the physicians via phone stating: 1. They had recently received may have an incorrect MSI-H result which could be erroneous due to a possible false positive and to not use the MSI analyte to prescribe treatment. 2. The prescribing physicians were also told that an amended report designating MSI as undetermined would be issued immediately. 3. The physicians were asked if any treatment plan using the MSI result had been started and all confirmed that no treatment plan utilizing the MSI analyte had been used. 4. They were also informed of the availability of FMI Medical Affa |
| Quantity | 8 reports |
| Distribution | MA, NC,IN, OH, GA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.