FDA Medical devices recall ·
MI Cancer Seek recall
- Recall number
- Z-2521-2025
- Date
- (initiated June 17, 2025)
- Company / brand
- Caris Life Sciences
350 W Washington St Fl 4, Tempe, AZ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF Serial Number: H5HJHDSXF
Distribution
U.S. Nationwide distribution in the state of NY.
States: New York
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2521-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.