FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2521-2025
- Recalling firm
- CARIS LIFE SCIENCES
- Product
- 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.
- Status
- Open, Classified
- Initiated
- 2025-06-17
- Posted
- 2025-09-04
- Terminated
- not on file
- 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 paying careful attention to the amended CDx report with the header "MI Cancer Seek" which changes the wild-type KRAS/NRAS result Detected to wild-type KRAS/NRAS result to Not Detected and the KRAS G12C variant listed in the Other Alterations and Biomarkers Identified section towards the bottom of the page. The new CDx report also includes the banner, Findings did not yield any biomarker results with Companion Diagnostic (CDx) claims . For questions, contact Regulatory Affairs at 351-220-3883 Monday thru Friday 8:00 AM to 5:00 PM Mountain Standard Time or email Pcarter@carisls.com. In addition Caris Customer Support +1-888-979-8669
- Quantity
- 1
- Distribution
- U.S. Nationwide distribution in the state of NY.
- Lot, serial or model codes
- Catalog Number: MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF Serial Number: H5HJHDSXF
- 510(k) numbers
- not on file
- PMA numbers
- ["P240010"]
- Product code
- PQP
- Firm FEI
- 3008335090
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28