MI Cancer Seek REF MSC000 recallZ-2521-2025 · Caris Life Sciences · initiated Jun 17, 2025

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Caris Life Sciences or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation

FDA root cause category: Software design

What the company is doing

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 [email protected]. In addition Caris Customer Support +1-888-979-8669

Recall details

Recall number: Z-2521-2025
Status: Open, Classified
Initiated by the company: Jun 17, 2025
Posted by the FDA: Sep 4, 2025
Recalling firm: Caris Life Sciences
Quantity: 1
Product code: PQP
FDA submissions: P240010
Distribution: U.S. Nationwide distribution in the state of NY.

Product description

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.

Code information (models, lots, serial numbers)

Catalog Number: MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF Serial Number: H5HJHDSXF

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

MI Cancer Seek® MCS000
Caris Mpi, Inc. · Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

How recalls are matched to devices · Editorial policy · Report an error on this page