Z-2521-2025Class II

MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay...

Name: Z-2521-2025 MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay...
Creator: Caris Life Sciences
Published: 2025-06-17
License: https://open.fda.gov/license/

Caris MPI, Inc / initiated 2025-06-17 / Open, Classified / root cause: software

FDA source

CARIS LIFE SCIENCES began a recall of 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... on 2025-06-17. FDA classified it as Class II and gives the reason as "Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2521-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-17
Posted: 2025-09-04
Recalling firm: Caris MPI, Inc
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.
Product code: PQP Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Reason for recall: Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
Root cause tag: software
FDA 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 [email protected]. In addition Caris Customer Support +1-888-979-8669
Quantity in commerce: 1
Distribution: U.S. Nationwide distribution in the state of NY.
Product codes and lots: Catalog Number: MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF Serial Number: H5HJHDSXF

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2521-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2521-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-04

Product code PQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)