Medical device assay recalled for incorrect test results and therapy recommendations
The MI Cancer Seek assay is being recalled because it provided incorrect test results that led to incorrect drug therapy recommendations for cancer patients.
What this means for you
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: This is an FDA Class II medical device with incorrect test results leading to incorrect therapy recommendations. No hospitalization or reported injuries are documented, but the device presents a risk of harm through inaccurate diagnostic information for cancer treatment planning.
Plain-English summary
The FDA is recalling the MI Cancer Seek REF MSC000, a diagnostic assay manufactured by Caris Life Sciences. The assay provides tumor mutational profiling for cancer patients and is intended to be used by qualified healthcare professionals for oncology treatment planning.
The recall is due to incorrect test results being provided that indicated incorrect drug therapy recommendations. This means patients received test results that did not accurately reflect their tumor profile.
The affected assay (Catalog Number MSC000, UDI Code (01)00860008613325(21)H5HJHDSXF, Serial Number H5HJHDSXF) was distributed nationwide, including in New York. Patients and healthcare providers who received results from this assay should consult with their healthcare team regarding the accuracy of those results.
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 wi
- Manufacturer
- CARIS LIFE SCIENCES
- Hazard
- inaccurate-results
- incorrect-therapy-recommendation
Distribution
Distributed nationwide across the United States.
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