The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2521-2025·Announced 2025-09-10

Tumor profiling assay recalled after incorrect result gave wrong therapy recommendation

One MI Cancer Seek tumor mutational profiling assay is recalled because an incorrect test result was provided that indicated the incorrect drug therapy recommendation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice states an incorrect result led to an incorrect drug therapy recommendation, with no injuries reported.

Plain-English summary

MI Cancer Seek, REF MSC000, UDI code (01)00860008613325(21)H5HJHDSXF, serial number H5HJHDSXF, is being recalled. The assay is a single-site test intended to provide tumor mutational profiling for use by qualified healthcare professionals in accordance with professional oncology guidelines. The recall covers 1 unit distributed in New York.

The recall was issued because an incorrect test result was provided that indicated the incorrect drug therapy recommendation. The FDA classified the action as Class II.

The laboratory and treating clinicians should follow the manufacturer's instructions on reviewing the affected result.

The recalled product

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…
Manufacturer
CARIS LIFE SCIENCES
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
1

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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