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U.S. Department of Health and Human Services

Class 2 Device Recall MI Cancer Seek

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 Class 2 Device Recall MI Cancer Seeksee related information
Date Initiated by FirmJune 17, 2025
Date PostedSeptember 04, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2521-2025
Recall Event ID 97258
PMA NumberP240010 
Product Classification Next generation sequencing oncology panel, somatic or germline variant detection system - Product Code PQP
ProductMI 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 Catalog Number: MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF Serial Number: H5HJHDSXF
FEI Number 3017020141
Recalling Firm/
Manufacturer		 CARIS LIFE SCIENCES
350 W Washington St Fl 4
Tempe AZ 85288-1495
For Additional Information ContactPeggy Carter
351-220-3883
Manufacturer Reason
for Recall		Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
FDA Determined
Cause 2		Software design
ActionOn 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 in Commerce1
DistributionU.S. Nationwide distribution in the state of NY.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = PQP
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