Safety Alert: Class II: Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
healthClass IIRecalled on Sep 10, 2025
MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational pro
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Sold At: CARIS LIFE SCIENCES(U.S. Nationwide distribution in the state of NY.)
Recall #: FDA-DEVICE-Z-2521-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Catalog Number: MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF Serial Number: H5HJHDSXF
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Summary
Due to an incorrect test results provided that indicated the incorrect drug therapy recommendation
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact CARIS LIFE SCIENCES for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.