Recall Z-2521-2025 ยท PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
CARIS LIFE SCIENCES
MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.
| Date | Sep 4, 2025 (initiated Jun 17, 2025) |
| Status | Open, Classified |
| Reason | Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation |
| Root cause | Software design |
| Action | On 07/14/2025, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter its customer that inform them that an incorrect CDx report was issued on April 14, 2025 with the wild-type KRAS/NRAS results with VECTIBIX (panitumumab) listed as a therapeutic option. The potential cause of the issue occurred due to two unanticipated events occurring in succession within the operational aspect of the report generation software processes of MI Cancer Seek. These two events in succession resulted in a failing file. Customer was provided with an amended report and instructed to: -Review the report payin |
| Quantity | 1 |
| Distribution | U.S. Nationwide distribution in the state of NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.