Reported Sep 10, 2025 · Ongoing

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

Caris Life Sciences

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CARIS LIFE SCIENCES · 350 W Washington St Fl 4 · Tempe, AZ · 85288-1495

Is this the product you have?

  • 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
Lot codes and dates
  • Catalog NumberMSC000
  • UDI Code(01)00860008613325(21)H5HJHDSXF
  • Serial NumberH5HJHDSXF
Amount recalled
1

Where it was sold

  • Nationwide
  • NY

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Caris Life Sciences recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.