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RecallWatchMedical Device Safety
Class IIOngoingZ-2521-2025

CARIS LIFE SCIENCES recalls MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek…

CARIS LIFE SCIENCESTempe, AZ, United StatesReported Sep 10, 2025 · 10 months ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI CodeCatalog # Number
    Affected lot
    H5HJHDSXF

What the firm 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 Pcarter@carisls.com. In addition Caris Customer Support +1-888-979-8669

DistributionShow details

U.S. Nationwide distribution in the state of NY.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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